Operations Supervisor

Platform Engineer

Buyer II

MGR II Laboratory

Quality Control Supervisor

Inspector 4

Senior Quality Engineer

Lead Quality Specialist - Investigator

Regulatory Affairs Manager

Role Description: <ul><li>Job Summary The Operations Supervisor is responsible for overseeing solid dosage pharmaceutical manufacturing and packaging activities during 2nd shift operations, 3:15pm to 11:45pm.&nbsp;</li><li>This role ensures that all production operations comply with cGMP, safety standards, and production schedules.</li><li>The operations supervisor will lead and support a team of leads and operators ensuring high quality output, operational efficiency, and a safe working environment.</li><li>Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&amp;L responsibility, etc.</li><li>Oversees and coordinates Manufacturing and Packaging operations.&nbsp;</li></ul> Responsibilities: Key Accountabilities: <ul><li>Accountability Lead and supervise operations in solid dosage manufacturing and packaging to ensure adherence to Master Formula and Master Packaging Records, SOP’s, and regulatory requirements (FDA, etc.).</li><li>Communicate with department leadership, set the shift schedule, and conduct shift huddle/communication at start of shift to ensure effective communication between shifts.</li><li>Ensure timely execution of production schedules.</li><li>Monitors manufacturing and packaging processes to ensure schedule is met within standards.</li><li>Review and complete shift documentation, including batch documentation, logbooks, etc.</li><li>Coordinate with Engineering and Quality Assurance to address any equipment issues that occur during the shift Support investigations for deviations that occur during the shift.</li><li>Assist in determining and implementing CAPA.</li><li>Provide training, guidance, and performance feedback for shift employees.</li><li>Ensure training requirements are met.</li><li>Support employee development and cross-training.</li><li>Executes procedures to complete tasks in a compliant and safe manner.</li></ul> Continuous Improvement <ul><li>Captures and reports metrics; troubleshoots downtime to increase operational efficiency.</li><li>Lead or participate in Continuous Improvement projects.</li><li>Troubleshoots and resolves process issues.</li></ul> Issues &amp; Deviations <ul><li>Performs defect evaluations and initiates production events.</li><li>Identifies, reports, and suggests resolutions for processing related issues.&nbsp;</li><li>Assists in the investigation of unplanned deviations.</li></ul> Teamwork and Collaboration <ul><li>Provides priorities for the off-shift operations, focusing resources on priority products.</li><li>Interfaces with supervisors and/or Quality personnel to inform of deviations or other line issues.</li><li>Continuous Training Ensures personnel are current with training requirements.</li><li>Stays current on SOPs and cGMPs.</li><li>Continuous Safety &amp; Compliance Contribute to safety audits.</li><li>Ensures out manufacturing/packaging activities safely, as required, on a daily basis.</li><li>Follows all safety and compliance procedures and participates in required training.</li><li>Adheres to all cGMP compliance/regulatory mandates and quality requirements.</li><li>Participate in safety teams, start-up discussions, incident debriefs, etc.</li><li>Ensures compliance with SOPs, Policies and Procedures as required by the Company and regulatory agencies.</li><li>Misc Other related duties as assigned to meet departmental and Company objectives.&nbsp;</li></ul> Requirements: Qualifications Education &amp; Experience: <ul><li>Minimal acceptable level of education, work experience and certifications required for the job Bachelor’s degree in pharmacy, Chemistry, Engineering, or a related discipline preferred, relevant experience my substitute.</li><li>Minimum of 3 years supervisory experience in pharmaceutical solid dosage manufacturing/packaging.&nbsp;</li><li>Knowledge Proficiency in a body of information required for the job e.g.</li><li>Knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li><li>Thorough knowledge of cGMP and FDA regulations.</li><li>Thorough knowledge of manufacturing and packaging operations.&nbsp;</li></ul> Skills &amp; Abilities: <ul><li>Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.</li><li>Demonstrated leadership, communication, and decision-making skills.</li><li>Ability to oversee and manage the daily operations of manufacturing and packaging. Ability to monitors processes to ensure schedule is met within standards.</li><li>Ability to analyze metrics and troubleshoot downtime.&nbsp;</li><li>Effectively interfaces with Quality Assurance to inform of deviations or other line issues.</li><li>Demonstrates the ability to work in collaboration with others as a part of a team.</li><li>Ability to lead in Continuous Improvement projects.</li><li>Possess technical writing skills.&nbsp;</li><li>Physical Requirements Physical &amp; mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.</li><li>Must be able to stand for long periods of time (8- or 12-hour shifts), lift at least 35 pounds, climb ladders, wear a dust mask or respirator and pass associated respirator tests and/or requirements, and be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes.</li></ul>

Responsibilities: <ul><li>The Professional, Platform Engineering job maintains and partners to design and develop digital technology infrastructure to support information technology applications and services.</li><li>With limited supervision, this job collaborates with cross functional teams to implement new software features to meet user needs and business goals and upgrade existing platforms to improve performance and functionality through writing clean, efficient and scalable code and troubleshooting and debugging moderately complex issues.</li><li>This job also participates in code reviews to maintain high code quality and share knowledge with platform engineering team members.&nbsp;</li><li>SOFTWARE DEVELOPMENT: Partners to design and develop high quality software solutions by writing clean, maintainable and efficient codes.&nbsp;</li><li>AUTOMATION: Applies internal software deployment platform, continuous integration or continuous delivery pipeline and twelve factor development methodology to automate the deployment process, ensuring smooth and reliable releases.</li><li>COLLABORATION: Partners with cross functional team of product managers, designers and other engineers to gather moderately complex requirements and deliver solutions that meet business needs.</li><li>TESTING &amp; DEBUGGING: Writes and maintains moderately complex unit tests and integration tests, and performs debugging to maintain the quality and performance of the software, applying test driven development as needed.</li><li>CONTINUOUS IMPROVEMENT: Identifies and suggests options for improving the software development and deployment processes, and implements the approved standards to improve efficiency and reliability.</li><li>DOCUMENTATION: Drafts and maintains comprehensive documentation for moderately complex software applications, deployment processes and system configurations.</li><li>TECHNICAL SUPPORT: Provides technical support and troubleshooting for moderately complex issues with deployed applications to ensure minimal downtime and fast resolution.</li></ul> Requirements: <ul><li>Minimum requirement of 2 years of relevant work experience.</li><li>Typically reflects 3 years or more of relevant experience.</li><li>Preferred Qualifications</li><li>Proficient in JavaScript, Java and Python</li></ul>

Responsibilities: <ul><li>Support migration of Indirect Procurement processes from other Global countries to Alabang and prepare Indirect Procurement related process documentation (process maps and work instructions)</li><li>Become a Subject Matter Expert for Indirect Procurement related topics</li><li>Handle and resolve escalated procurement processing issues</li><li>Answer and resolve suppliers, stakeholders and AP queries to ensure timely resolution&nbsp;</li><li>Maintain supplier master data information in relevant systems</li><li>Ensure proper processing of PR’s and PO’s</li><li>Perform compliance checks&nbsp;</li><li>Expedite POs&nbsp;</li><li>Answer tickets (Procurement Helpdesk)</li><li>Manage invoice pricing issues</li><li>Create, maintain Info Record &amp; source lists</li><li>Spot Buy / Requisition Based Sourcing</li><li>Execute all procurement activities in-scope</li><li>Prepare and process eRFQ’s</li><li>Smaller Contract (value/complexity) negotiation &amp; execution&nbsp;</li><li>Execution of Projects assigned by Commodity Management&nbsp;</li><li>Desk Research and Price Comparison</li><li>Supplier training on tools</li><li>End-user Trainings</li><li>Savings reporting</li><li>Maintain communication with suppliers, stakeholders and other Indirect Procurement members</li><li>Execute periodically PR/PO audit queries or upon request KPI’s measurements</li><li>Ensure compliance with applicable company policies&nbsp;</li><li>Contribute to continuous improvement initiatives within the function, ensuring that improvements are incorporated in the work routine</li><li>Support robust compliance environment with applicable policies, procedures and processes</li><li>Build relationship with key stakeholders including suppliers</li><li>Support local BU owners, Function representatives or other Procurement team members to solve issues in a timely manner,</li><li>Build strong relationship with key stakeholders,</li><li>Attend team meetings and trainings as required.</li></ul> Requirements: <ul><li>Good Experience in Indirect Procurement (5+ years)</li><li>Previous experience in shared service environment</li><li>Good of MS office; very good Excel and other relevant tools for the function</li><li>SAP PR2, S/4</li><li>Good communication skills&nbsp;</li><li>Very good English language skills in speech and writing + additional language on top of Filipino</li><li>preferred (Chinese, Spanish, German, French, etc.)</li><li>Diversified Industrial Products/Manufacturing industry experience preferred</li><li>Good command of other languages is a very important asset</li></ul>

Responsibilities: Undertake overall Responsibility:&nbsp; <ul><li>Manage in FA function and leading modern technology to coordinating with engineering to develop core Tech and able to expand to lab levels for daily delegated tasks to manage the related database consolidation.&nbsp;</li><li>Driving with company OA improvement on process or capability improvement to make lab goals achieved and support engineering to win in markets.&nbsp;</li></ul> Responsible for Strategy:&nbsp;&nbsp; <ul><li>Set clear FA direction goals and develop strategies with high-level visions that reframes what winning looks like and approaches to fulfil modern technology assignments in creative and meaningful ways.</li><li>Providing strategy for FA/Lab directions align with organization value drivers and tactics to key program execution with excellence and flexible. </li><li>Such as Identify FA team with right size, people skills and address technical assistance to design feasibility and make recommendations for necessary changes.</li><li>Transform stakeholders need and assess FA/Lab capability tried-and-true options for scenarios allocate resources to high priorities (people, cost $, management attention, sustainability etc) to significantly shorten the product design cycle and help bring products to market faster while ensuring high quality and performance. </li><li>also sorts of possibilities to creating an optimal flow to shaping up team to be more engaging and easier to follow.</li><li>With financial knowledges to assess capability and predict organization forecast and analysis per budget scope, and build long-term constructive common ground network across the adjacent functions such as Product Engineering, Project Engineering and Field Application Engineering etc.&nbsp;</li><li>Align organization culture targeting and systematically pursuing specific areas for further secure lab competitiveness, i.e. (Software/ System/CoE/ 3DP/New Tech etc)&nbsp;</li></ul> Responsible for lab strategy mobilization and execution: <ul><li>Communicate and distribute the requirements per lab programs implementation keeps FA/Lab ahead of or at pace with the competition,</li><li>Boost and Outline the necessary investment plan of amount, relevance and quality of test equipment in FA/lab, driving efficiency to maximize value and return on investment.</li><li>Create and use systems for monitoring and manage various performance in FA function OKR/KPIs to process control and follow up and streamline the process and balance of stability and agility that maximizes the speed and effectiveness by using digital data-driven techniques, show diagram visually.</li><li>Broad knowledge to develop FA/Test/3DP etc method per core technology to foster FA/lab growing, and design new correction/prevention quality initiatives to pinpoint the risks and minimize lab operation obstacles, build resilience ahead of any potential crises and update risk assessments so that enable lab able to mitigate the impact and unlock opportunities.</li><li>Define FA/Lab operation mechanism, criteria, and management discipline to ensure FA/Lab for daily work what is in good working order.</li><li>Leading Team use data to make timely decisions.&nbsp;</li><li>Research new development method and set guidelines enables engineering/manufacturers to better process control and maintain quality within acceptable limits to prevent failure in early stage, approaching smart tech to accelerate the testing,inspection and analysis activities,&nbsp;</li></ul> Succession Talent Effectiveness:&nbsp; <ul><li>Identify key talents per OLR and drive team and equip team development goals to ensure most value-creating roles in lab filled with right position.</li><li>Capable with management skills to prepare effective office support in place, such as Give Training and properly communicate findings so as to help team to continuously improving their abilities to ensure lab organization successfully and sustainable as whole team can do or to achieving next level."</li></ul> Requirements: <ul><li>Master’s degree or above level of qualification in Engineering technology areas</li><li>Minimum 8+years of similar industry Engineering field and for management, English listening, speaking, writing ability are required.</li><li>Experience in technical technology on validation test, Failure Analysis, or 3D printing, tool application or system Engineering preferred.</li><li>Proactive oriented and tenacity to results driven.</li><li>practitioner well on logic and structure skills</li><li>Manager level experiences with ISO/IEC 17025 lab system standards and engineering skills</li><li>Demonstrated ability in conducting audits and all aspects of communication, collaboration and team building skills.</li><li>Proficient ability in developed the new tech to reduce redundant testing or inspection activities, or experience for new program/project boosting and launch preferred.</li><li>Outstanding engineering background and Test field for now organization management and with software capabilities would prefer.</li></ul>

Role Description: <ul><li>A concise overview of the job The Supervisor, Quality Control is responsible for overseeing the day-to-day operations of the QC raw material testing group.</li><li>Supervision and enforcing cGMP’s, GLP’s, conducting investigations, method transfers, verifications of compendia methods and training of new employees.</li><li>All incumbents are responsible for following applicable Division &amp; Company policies and procedures.</li><li>Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority (capital, operating, etc.), P&amp;L responsibility, etc.</li><li>Supervisory responsibilities within a single site.</li></ul> Responsibilities: <ul><li>QC Lab Management- Supervise day-to-day operations of QC Laboratory to ensure that cGMP’s, GLP’s and all other applicable compendial requirements are met.</li><li>Ensure that the testing is done as per the approved monograph procedures, investigate and take corrective actions, document investigation findings and coordinate the approval process of investigations.</li><li>Interact with Planning, Purchasing, Supply Chain, Production, QA for timely release of raw materials, excipient and packaging components.</li><li>Coordinate Analytical Methods Transfer projects. Identify and implement procedures to reduce cost of goods.</li><li>Develop systems and processes for proactive management of laboratory logistics and instrumentation.</li><li>Oversee ordering of lab supplies in observance of Departmental Budget constraints.</li><li>Workload Management- Coordinate workload sharing with other groups in QC and develop action plans to improve the working environment and for maximization of laboratory efficiency.</li><li>Prepare monthly report of the issues, work done, any employee related issues and conduct bi-weekly audits of the analyst’s notebooks.</li><li>SOPs - Review/update SOP’s, procedures and monographs for the QC Group as needed.</li><li>Review and comment on the articles affecting QC in the USP Supplements and Pharmacopeial Forums.</li><li>Conduct periodic audits of the analyst notebooks and instrument logbooks to ensure compliance of cGMP’s.</li><li>Staff Development-Evaluate potential candidates for QC; performance evaluation of direct reports.</li><li>Provide training in all procedures/instrumentation/techniques, including but not limited to HPLC, UV-Vis, IR, and Raw Material, Finished Product, Stability testing. 15% Total	100% Qualifications&nbsp;</li></ul> Requirements: Education &amp; Experience <ul><li>Minimal acceptable level of education, work experience and certifications required for the job</li><li>BS in chemistry or related discipline with 10+ years’ experience in pharmaceutical testing OR MS in Chemistry or related discipline with 7+ years’ experience in pharmaceutical testing.</li><li>3+ years’ QC lab supervisory experience in pharmaceutical industry.</li><li>Demonstrated management and leadership experience with strong interpersonal and influencing skills.</li></ul> Knowledge&nbsp; <ul><li>Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li><li>Expert knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or SDS.</li><li>Strong knowledge and proficiency required with laboratory techniques/instruments, such as HPLC, GC, analytical balance, pipette, burette, oven, UV-vis spectrophotometer, dissolution tester, pH meter, etc.</li><li>Strong knowledge and proficiency preferred with Empower, Track Wise and Labware LIMS.</li></ul> Skills &amp; Abilities	 <ul><li>Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.</li><li>Organizational Support- Follows policies and procedures; completes administrative tasks correctly and on time; supports organizations goals and values; benefits organization through outside activities; supports affirmative action and respects diversity.</li><li>Leadership - Exhibits confidence in self and others; inspires and motivates others to perform well; effectively influences actions and opinions of others; accepts feedback from others; gives appropriate recognition to others.</li><li>Supervising People- Includes staff in planning, decision-making, facilitating and process improvement; takes responsibility for subordinates activities; is available to staff; provides regular performance feedback; develops subordinates skills and encourages growth; solicits and applies customer feedback (internal and external); fosters quality focus in others; improves processes, products and services.; continually works to improve supervisory skills.</li><li>Quality - Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality.</li><li>Demonstrated flexibility in carrying out varied assignments in a high-quality work environment.</li><li>Excellent written and oral communications skills with a strong emphasis on organizational capabilities.</li></ul> Physical Requirements	 <ul><li>Physical &amp; mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.</li><li>Employee is frequently required to use hands to handle or feel.</li><li>The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision and color vision.</li><li>The noise level in the work environment is usually moderate.</li><li>The work environment is representative of a group laboratory environment.</li><li>QC Lab Management, Workload Management, SOPs, Staff Development</li></ul>

Responsibilities: <ul><li>Inspect parts for material defects and irregularities.</li><li>Conduct tests with appropriate NDT technique(s).</li><li>Interpret, evaluate, and document results.</li><li>Generate NDT report, organize report and evaluate data for disposition.</li><li>Support product &amp; process failure root cause analysis.</li><li>Identify and resolve problems in a timely manner.</li><li>Obtain and analyze information skillfully.</li><li>Provide support to manufacturing departmental Quality Control Inspectors, as necessary, to ensure that products and processes comply with the relevant requirements of the quality management system.</li><li>Prepare QA reports as directed by the QA Manager.</li><li>Support the control of Non-conforming material process.</li><li>Support Calibration of equipment.</li><li>Work with cross-functional teams to improve processes and to drive product quality.</li><li>Assist in the development of quality plans, implement established methods for new and existing products for inspection and test procedures.</li><li>Other appropriate duties as assigned</li></ul> Requirements: <ul><li>Must be US citizen due to access to products and technology controlled under the ITAR &amp; EAR</li><li>Quality - demonstrates accuracy, thoroughness and monitors own work.</li><li>Safety - actively promotes safety procedures; use all equipment and materials properly.</li><li>Oral Communication - Speak clearly and persuasively in positive or negative situations.</li><li>Written Communication - Edit and present numerical data effectively.</li><li>Interpersonal Skills - maintain confidentiality.</li><li>Planning / Organization - Prioritize and plan work activities using time efficiently.</li><li>Adaptability - Ability to adapt to changes in the work environment.</li><li>Must be familiar with the codes, standards and other contractual documents that control the method as utilized.</li><li>High level of attention to detail and accuracy. Good organization, verbal, writing and listening skills.</li><li>Work independently in a team environment. Must be proficient with Microsoft Office applications (Word, Excel, PPT, etc.) Working knowledge of ISO 9001.</li></ul>

Responsibilities: <ul><li>Develop and implement quality standards to meet Quality Management System to assure products meet or exceed customer expectations.</li><li>Lead cross-functional problem-solving teams; use of QA methodologies to manage and facilitate issue resolution including root cause investigations and the development, implementation and monitoring of effective corrective and preventive actions</li><li>Performs routine supplier and plant audits to ensure product being manufactured meets all requirements.</li><li>Lead cross-functional teams to drive process and product improvements in manufacturing plants and at suppliers.</li><li>Work with Manufacturing, Engineering, and PM to determine product specifications and tolerances.</li><li>Participates in various NPI projects to ensure quality is incorporated into product designs and be responsible for preparing all quality-related documentation.</li><li>Support the development of FMEAs, Control Plans, Test and Inspection Plans.</li><li>Establish and maintain control plans to assure critical features are controlled through manufacturing processes.</li><li>Reviews and integrates contractual requirements into all aspects of proposals and program processes and documentation.</li><li>Conducts capability assessments and process validations to support supplier selection activities.</li><li>Provides material review dispositions for non-conforming materials or products.</li><li>Plan, execute, and oversee inspection and testing of products to verify conformance with specifications and deliverables.</li><li>Update company complaint handling system to ensure capture, investigation, and proper documentation of all customer complaints.</li><li>Manage documents related to ISO certification, procedures, standards, customer change requests, ECN, PCN, and/or Work Instructions.</li></ul> Requirements: <ul><li>Bachelor’s degree, Engineering or related technical discipline.</li><li>8+ years’ experience in Quality Engineer role in a production environment.</li><li>Familiarity with ISO 9001, AS9100 or ISO/TS 16949 QMS standards.</li><li>Experience in reading blueprints and have basic understanding of GD&amp;T fundamentals.</li><li>Experience effectively utilizing statistical methods and statistical analysis tools.</li><li>Experience with APQP, PPAP, FMEA, Control Plans, and various problem solving tools.</li><li>Experience in statistical tools and disciplined problem-solving methodologies such as 8D, A3, DMAIC, Fishbone,5-Whys, 6Ms.</li><li>Self-motivated, proactive and efficient team player who thrives in a fast-paced environment.</li><li>Able to travel 20% - 30% domestically and 10% internationally.</li><li>Must be eligible to work in the US with no sponsorship now or in the future.</li><li>Technical understanding of electrical power systems and electrical power distribution/circuit protection products.</li><li>Six Sigma Green, Black Belt, or comparable certification, preferred.</li><li>Excellent communication skills written, verbal, and presentation skills with effective technical writing skills, ability to speak Spanish is a plus.</li><li>High-energy, results-oriented, self-reliant, team player who can positively collaborate across different business departments and cultures.</li><li>Advanced knowledge of Microsoft Office (Word, Excel, PowerPoint, Outlook)</li><li>Experience in the electrical-mechanical manufacturing or solar industry.</li><li>Experience in conducting supplier and plant audits.</li><li>Experience in reviewing customer contracts.</li></ul>

Role Description: <ul><li>The Lead Quality Specialist - Investigator serves as the primary investigator for Out of Specification (OOS), Out of Trend (OOT), Non-Official Events (NOE), and other laboratory investigations within the Quality Control (QC) department.</li><li>This role is responsible for initiating, conducting, and closing laboratory investigations while collaborating with cross-functional teams to ensure accurate root cause analyses, effective Corrective and Preventive Actions (CAPAs), and adherence to compliance requirements.</li><li>Frequent interaction with QC, QA, Manufacturing, and other departments is essential to achieve timely investigation closure and process improvements.</li></ul> Scope of Authority <ul><li>Provides investigative and compliance support to the QC laboratory, with a focus on maintaining quality standards and supporting cross-departmental collaboration.</li></ul> Responsibilities; 1. Initiation, Execution, and Closure of QC Lab Investigations (60%) <ul><li>Initiate and conduct OOS, OOT, and NOE investigations in alignment with procedural timelines.</li><li>Provide support and guidance to QC teams during execution, writing, and closure of investigations.</li><li>Conduct interviews with QC personnel to gather information and complete investigation reports in Trackwise.</li><li>Utilize laboratory software for root cause and impact analyses.</li><li>Conduct quality walkthroughs in the QC laboratory to identify and address compliance issues.</li><li>Regularly communicate with departmental leaders to provide updates on investigation progress and documentation needs.</li></ul> 2. Corrective and Preventive Actions (CAPAs) (30%) <ul><li>Collaborate with cross-functional teams to identify, implement, and monitor CAPAs within QC laboratories.</li><li>Assist with training, procedure updates, and monograph revisions based on investigation outcomes.</li><li>Provide recommendations for process improvements to support continuous improvement initiatives.</li></ul> 3. Compliance (10%) <ul><li>Identify compliance risks, propose remediation strategies, and lead the implementation of solutions.</li><li>Provide compliance expertise, training, and support to QC and other impacted departments.</li></ul> Requirements: Education &amp; Experience <ul><li>Bachelor’s degree in Chemistry, Biology, or Pharmaceutical Sciences.</li><li>Minimum of 4 years of experience in a pharmaceutical manufacturing environment.</li></ul> Knowledge <ul><li>Proficiency in HPLC, GC, and related chromatography methods and equipment.</li><li>Working knowledge of Chromatographic Data Systems (e.g., Empower preferred) and applications such as Trackwise.</li><li>Comprehensive understanding of QC lab testing and data integrity principles.</li><li>Familiarity with regulatory requirements, including 21-CFR-210, 21-CFR-211, ICH Guidelines, and Compendia standards (USP, EP, JP, etc.).</li></ul> Skills &amp; Abilities <ul><li>Strong technical writing and documentation skills.</li><li>Problem-solving and decision-making expertise.</li><li>Excellent communication skills with peers, chemists, and senior management.</li><li>Critical thinking and root cause analysis proficiency.</li><li>Customer and stakeholder focus, with a strong commitment to quality and integrity.</li><li>Physical &amp; Mental Requirements</li><li>Ability to sit, stand, walk, and use a computer for extended periods.</li><li>Exposure to moderate noise levels and various chemicals in an FDA- and DEA-regulated environment.</li><li>Ability to wear personal protective equipment (e.g., gloves, respirators).</li><li>Specific vision requirements include close vision and color vision.</li></ul>

Responsibilities: <ul><li>Ensure all products comply with applicable laws, regulations, and standards as per Indian laws</li><li>Stay updated on regulatory changes and assess their impact on the companys products or processes.</li><li>Either prepare or coordinate with originator, review, and submit regulatory documents such as dossiers, technical files, and applications for product approval or licensing.</li><li>To do necessary follow-ups with regulatory agencies to get approval of the medical devices/pharmaceutical products.</li><li>Work with Originator, and marketing teams to ensure product alignment with regulatory requirements.</li><li>Lead or assist in regulatory audits conducted by agencies or certification bodies.</li><li>Identify and mitigate regulatory risks that could impact product approvals or market access.</li><li>Develop and implement regulatory strategies to accelerate market entry and ensure sustained compliance.</li><li>Conduct training sessions for cross-functional teams on regulatory requirements and best practices.</li><li>Responsible to get the necessary documents which are going to be useful for registration purpose.</li><li>Usually, this registration application is done online, and you need to constantly keep a follow up with the regulatory team.</li><li>Responsible to liaise with the authority daily based on the requirements pertaining to document for the smooth transition with the regulator and submit regularly to the regulating authority to get the registration executed in a timely manner.</li><li>Front lining the entire process with respect to coordination with Originator, regulatory authority and in need be travel to Delhi for meetings.</li><li>The company has tied up with an agency to make sure there are no gaps and you will be responsible to liaise with the Agency who closely work with the government authority to satisfy the documentation requirements.</li><li>You will be also responsible to regularly interact and funnel the requirements with the agencies and the regulatory authorities.</li><li>Ensure all products comply with applicable laws, regulations, and standards as per Indian laws</li><li>Stay updated on regulatory changes and assess their impact on the companys products or processes.</li><li>Either prepare or coordinate with originator, review, and submit regulatory documents such as dossiers, technical files, and applications for product approval or licensing.</li><li>To do necessary follow-ups with regulatory agencies to get approval of the medical devices/pharmaceutical products.</li><li>Work with Originator, and marketing teams to ensure product alignment with regulatory requirements.</li><li>Lead or assist in regulatory audits conducted by agencies or certification bodies.</li><li>Identify and mitigate regulatory risks that could impact product approvals or market access.</li><li>Develop and implement regulatory strategies to accelerate market entry and ensure sustained compliance.</li><li>Conduct training sessions for cross-functional teams on regulatory requirements and best practices.</li></ul> Requirements: ﻿Skills and Qualifications <ul><li>Bachelors degree in Life Sciences, Pharmacy, Chemistry, Biomedical Engineering.</li><li>Advanced degree (e.g., MBA, MS, or Ph.D.) is an advantage.</li><li>Strong knowledge of regulatory requirements (CDSCO, FDA, EMA, MHRA, TGA, etc.) and global standards (ISO, ICH, etc.).</li><li>Excellent project management and organizational skills.</li><li>Ability to analyze and interpret complex regulations.</li><li>Proficient in regulatory writing and submission tools.</li><li>Strong communication and interpersonal skills.</li><li>Ability to manage multiple projects and meet deadlines.</li></ul> Experience <ul><li>7–8 years of experience in regulatory affairs, with a proven track record of successful submissions and approvals.</li><li>Experience in handling registration of Medical Devices and getting approval.</li></ul>

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Operations Supervisor

Platform Engineer

Buyer II

MGR II Laboratory

Quality Control Supervisor

Inspector 4

Senior Quality Engineer

Senior Quality Engineer

Lead Quality Specialist - Investigator

Regulatory Affairs Manager

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Operations Supervisor

Platform Engineer

Buyer II

MGR II Laboratory

Quality Control Supervisor

Inspector 4

Senior Quality Engineer

Senior Quality Engineer

Lead Quality Specialist - Investigator

Regulatory Affairs Manager

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