Lead Quality Specialist - Investigator

Institutional Manager – Device Business

Regulatory Affairs Manager

Team Leader Engineering

QC Chemist I

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>

Role Description: <ul><li>Looking for energetic, self-driven and focused sales professionals in SALES &amp; BUSINESS DEVELOPMENT DEPT roles to expand MEDICAL DEVICES business of our client in India who would support the journey of business expansion, expanding clientele base, and building new opportunities for business.</li></ul> Responsibilities: <ul><li>Develop and implement sales strategies to achieve revenue targets within the institutional segment.</li><li>Identify, build and maintain strong relationships with all types of institutional clients across India.</li><li>Participate in tenders in identified institutes and procure the tender business.</li><li>Identify new business opportunities and develop partnerships to expand the companys footprint in the institutional market.</li><li>Work closely with internal teams such as marketing and logistics to ensure seamless service delivery.</li><li>Achieve / surpass the sales target set for institutional business.</li></ul> Requirements: <ul><li>Minimum of 10-12 years in sales, with at least 7-8 years in institutional sales, preferably in the medical device or healthcare industry.</li><li>Bachelors degree in Life Sciences, Pharmacy, Chemistry, Biomedical Engineering. Advance degree (MBA, MS, PhD) would be advantage.</li><li>In depth knowledge of medical devices and the healthcare industry.</li><li>Proven track record of meeting or exceeding sales targets.</li><li>Strong relationship with institutional clients.</li><li>Excellent negotiation and communication skills.</li><li>Strong analytical and problem-solving abilities.</li><li>Willingness to travel extensively across India.</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>

Job Summary: <ul><li>The Regulatory Affairs Manager is responsible for ensuring that the companys products meet all regulatory requirements and standards in the markets where they are sold. This role involves managing the regulatory approval process, keeping up to date with regulatory changes, and ensuring compliance with all relevant laws and guidelines.&nbsp;</li><li>The Regulatory Affairs Manager will also collaborate with cross-functional teams to provide guidance on regulatory issues and strategies.</li></ul> Responsibilities: Regulatory Compliance and Strategy: <ul><li>Lead and manage regulatory submissions and ensure compliance with local regulations.</li><li>Develop regulatory strategies for the approval and commercialization of products or product changes.</li><li>Keep abreast of changing regulations and ensure the company remains in compliance with evolving regulatory environments.</li></ul> Product Registration and Documentation: <ul><li>Prepare, review, and submit regulatory documents, including product dossiers, to relevant regulatory agencies.</li><li>Coordinate with internal teams to ensure that all necessary documentation for regulatory submissions is accurate and complete.</li><li>Maintain regulatory files and ensure they are up to date and readily accessible.</li></ul> Cross-functional Collaboration: <ul><li>Work closely with marketing teams to provide regulatory input and ensure compliance is integrated into the planning.</li><li>Provide regulatory guidance and support to cross-functional teams, ensuring the timely and successful approval of products or product changes.</li><li>Assist in the preparation of marketing materials and labeling to ensure compliance with regulatory requirements.</li></ul> Regulatory Approval Process: <ul><li>Manage the regulatory approval process for products, product changes, and renewals, ensuring timely approvals in target markets.</li><li>Communicate with regulatory agencies as needed to clarify issues, respond to inquiries, or resolve regulatory concerns.</li></ul> Risk Assessment and Compliance Monitoring: <ul><li>Identify regulatory risks related to marketing, or distribution, and recommend mitigation strategies.</li><li>Monitor product performance post-market to ensure continued compliance with regulatory requirements.</li><li>Review and assess the impact of new or revised regulations on current and future products.</li></ul> Regulatory Affairs Training: <ul><li>Educate and train internal teams on regulatory affairs and compliance requirements.</li><li>Conduct workshops or presentations to ensure team members are aware of regulatory standards and best practices.</li></ul> Regulatory Reporting and Documentation: <ul><li>Maintain and track regulatory submissions and approvals, preparing status reports for senior management.</li><li>Prepare regulatory updates and reports for regulatory authorities, as needed.</li></ul> Audit and Inspection Support: <ul><li>Support internal and external audits related to regulatory compliance.</li><li>Participate in regulatory inspections or audits and manage the documentation and communication during such events.</li></ul> Requirements: Education:&nbsp; <ul><li>Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, Regulatory Affairs, or a related field.</li></ul> Experience:&nbsp; <ul><li>5+ years of experience in regulatory affairs, preferably in the relevant industry (e.g., pharmaceuticals, medical devices, direct-to-consumer).</li></ul> Knowledge:&nbsp; <ul><li>In-depth knowledge of local regulatory requirements and regulatory submission processes.</li></ul> Skills: <ul><li>Strong communication, organizational, and project management skills.</li><li>Ability to interpret and apply regulatory guidelines and laws.</li><li>Excellent attention to detail and ability to manage multiple priorities.</li><li>Experience with regulatory submission software and tools.</li><li>Ability to work cross-functionally with different departments and stakeholders.</li></ul>

Responsibilities: <ul><li>Manage day to day team activities of key account focused FAE(Field Application Engineer) team in the FAE US department&nbsp;</li><li>Manage all HR topics of the team&nbsp;</li><li>Train new team members in their role as key account focused FAEs&nbsp;</li><li>Advise and guide team members on key account specific business and technical details&nbsp;</li><li>Provide FAE US internal second level support for key account escalations&nbsp;</li><li>&nbsp;Develop implementation strategies for account specific key elements of technology and product roadmaps.</li><li>Condense key account FAE feedback into technology and product roadmaps and project pipelines in order to provide a unified voice to the BUs and Corporate R&amp;D.</li><li>Integrate IDM focused global FAE input and feedback into key account NPI activities, escalation handling, product improvement projects, and product roadmap development</li><li>Contribute team input and customer application knowledge to local and global reporting through Account Team meetings, local company meetings, QBRs, TRMs, Competence Centers, Account Summits, Global Sales Meetings&nbsp;</li><li>Cover team member substitution tasks&nbsp;</li><li>Cover Engineering Manager substitution tasks&nbsp;</li></ul> Requirements: <ul><li>Solid experience in vacuum engineering, preferably in the SEMI / Display / Solar industries.</li><li>Extensive exposure to developing products on system or sub-system level preferable in SEMI / Display / Solar industries.</li><li>University degree in Physics, Chemistry, Microelectronics, Mechanical, Electrical, or Semiconductor related engineering disciplines.</li><li>Min 7 years experience in vacuum engineering.</li><li>Affinity for people management and desire to care for individual team members and the whole team.</li><li>Good communication skills (verbal and written).</li><li>Awareness of on-time delivery, quality, and meeting commitments.</li><li>Technical skills in the field of customer processes, valve applications, and / or platforms.</li><li>Fluent in English (verbal and written) for communication with customers</li><li>Ability to work in a global matrix organization.</li></ul>

Responsibilities:The Chemist I, under direct supervision, learns and performs QC laboratory chemical analyses of raw materials, in-process materials, stability and finished products, and testing to support process validation.May participate in investigations.Learns and stays current with regulatory guidances and compendia relevant to laboratories and pharmaceutical manufacturing.Conducts routine laboratory analyses: finished product testing, stability testing, raw material testing, cleaning verification testing and manufacturing in-process testing.Typical activities may include buffer/solution preparation, standard preparation and operating analytical instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. Uses laboratory software for analyses.Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeepingCleans lab working surfaces and disposes of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals.Under close supervision, learns to troubleshoot basic instrument problems.With guidance, participates in OOS/OOT/NOE and other investigations.Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor.May assist in drafting, editing, and reviewing SOPs and laboratory investigations.Maintains assigned training records current and in-compliance.May assist in the training of less senior laboratory staff.Performs assigned work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting.Document accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs.Follows internal processes related to controlled substances continuous.Follows EH&S procedures to ensure a safe work environment.Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS continuous.Requirements:Minimal acceptable level of education, work experience and certifications required for the job.Bachelor of Science Degree in chemistry, chemical engineering or related field with analytical chemistry coursework required. Some pharmaceutical laboratory experience preferred.Proficiency in a body of information required for the job.e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.Proficiency with various laboratory techniques/instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. Basic knowledge of wet chemistry techniques.Knowledge of applicable safety and standards guidelines: SOP, cGMP, GLP, DEA regulations and/or MSDS.Competency in Microsoft Office Suite.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.Ability to display and analyze data in a logical manner.Good verbal and written communication skills as well as good computer skills.Attention to details and accurate record keeping.Establish and maintain cooperative working relationships with othersSolid organizational skills.Ability to take initiative, set priorities and follow through on assignments.Physical & mental requirements e.g., lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel. Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicalsMust occasionally lift and/or move up to 15-25 lbs.Ability to wear personal protective equipment, including respirators, gloves, etc. Specific visions abilities are required by this job include close vision and color vision.Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods.

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6 chemistry Jobs found

Lead Quality Specialist - Investigator

Institutional Manager – Device Business

Regulatory Affairs Manager

Regulatory Affairs Manager

Team Leader Engineering

QC Chemist I

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6 chemistry Jobs found

Lead Quality Specialist - Investigator

Institutional Manager – Device Business

Regulatory Affairs Manager

Regulatory Affairs Manager

Team Leader Engineering

QC Chemist I

WhiteCrow WhiteCrow is on a mission to connect companies with the best talent across the globe.

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