Product Manager (Pharma)

Area Sales Manager

Area Sales Manager - Europe

Customer Quality Engineer

Team Lead - Global Trade Compliance

ServiceNow Consultant

Customer Service Advisor (Senior Analyst)

Operation Supervisor

Electrical/Controls Technician

Lead Quality Specialist - Investigator

Overview: <ul><li>We are seeking a dynamic and results-driven Product Manager to join our team.&nbsp;</li><li>This position will play a key role in the development, launch, and lifecycle management of products. The ideal candidate with have a strong understanding of the pharmaceutical industry, market trends, and regulatory processes, along with excellent strategic and communication skills.</li></ul> Responsibilities: Product Strategy &amp; Development: <ul><li>Define and execute the product strategy for assigned therapeutic areas/products.</li><li>Work cross-functionally with internal teams to ensure product development and delivery aligns with market needs.</li><li>Lead the creation and execution of product launch plans, ensuring timely market&nbsp;</li><li>entry.</li></ul> Market Research &amp; Analysis: <ul><li>Conduct market analysis to identify customer needs, competitor products, and emerging trends within the pharmaceutical industry.</li><li>Analyze clinical trial data and product performance to provide insights for product positioning and lifecycle management.</li></ul> Cross-functional Collaboration: <ul><li>Collaborate with Sales and Marketing teams to develop promotional strategies and sales tools for product launches.</li><li>Work closely with regulatory affairs to ensure compliance with local and global regulations.</li></ul> Lifecycle Management: <ul><li>Develop and execute product lifecycle management plans, including post-launch support, updates, and potential product enhancements.</li><li>Monitor product performance and provide recommendations for improvements or&nbsp;</li></ul> Stakeholder Communication: <ul><li>Serve as the product expert and primary point of contact for internal stakeholders regarding product details, progress, and updates.</li><li>Communicate product strategies and key milestones to senior leadership, ensuring&nbsp;alignment with organizational goals.</li></ul> Financial &amp; Budget Oversight: <ul><li>Prepare and manage product budgets, ensuring efficient resource allocation.</li><li>Track and report on product financial performance, including sales forecasts, market share, and ROI.</li></ul> ﻿Requirements: <ul><li>Bachelor’s degree in Pharmacy, Life Sciences, Business, or related field&nbsp;</li><li>3-5 years of experience in product management, preferably within the pharmaceutical or&nbsp;</li><li>healthcare industry.</li><li>Proven track record of successfully launching and managing pharmaceutical products.</li><li>Excellent strategic thinking, problem-solving, and decision-making abilities.</li><li>Strong communication and interpersonal skills, with the ability to collaborate across diverse&nbsp;</li><li>teams.</li><li>Ability to analyze data, forecast trends, and translate insights into actionable strategies.</li><li>Experience with lifecycle management and managing product P&amp;L is highly desirable.</li></ul>

Overview: <ul><li>Oversee sales operations across multiple assigned countries, catering to a diverse portfolio of accounts, ranging from small and medium enterprises to larger clients.</li><li>Expand the customer base through proactive prospecting and business development, with a primary focus on small and medium-sized accounts in Pharma &amp; Nutra segment.</li></ul> Responsibilities: Strategic Planning and Execution: <ul><li>Design and implement pricing strategies tailored to accounts and key customers.</li><li>Identify and prioritize market-focused products to drive value growth for the organization.</li><li>Develop a deep understanding of the needs and expectations of accounts and key customers.</li><li>Craft a Key Account Management strategy aligned with Packaging Materials overarching business objectives.</li></ul> Core Functional Responsibilities: <ul><li>Develop the annual budget in collaboration with sales leaders, ensuring achievement of targeted sales volume and value.</li><li>Plan and conduct proactive customer visits and meetings to deepen understanding of customer requirements and build strong relationships.</li><li>Provide timely techno-commercial information and clarifications to address customer inquiries.</li><li>Regularly update customers on new product offerings and enhancements in the product range.</li><li>Devise alternative solutions to address supply challenges for specific orders.</li><li>Identify and pursue potential business opportunities, converting them into sustained revenue streams.</li><li>Implement corrective and preventive actions to resolve and avoid customer complaints effectively.</li><li>Recommend pricing strategies tailored to customer needs, ensuring approval and seamless implementation.</li><li>Gather and analyze customer and competitor data, including pricing, credit terms, volumes, business share, and quality assessments.</li><li>Maintain the budgeted ASP (Average Selling Price) to achieve the overall contribution outlined in the budget.</li></ul> Internal Process: <ul><li>Develop detailed, customer-specific plans to achieve targeted price realization and contribution.</li><li>Ensure timely collection of payments from customers in alignment with agreed terms.</li><li>Coordinate with the Group Sales team to promote combo deals, fostering deeper customer relationships.</li><li>Work closely with internal stakeholders across Films &amp; Foils to ensure seamless fulfillment of customer requirements.</li></ul> Key Result Areas: <ul><li>Improvement in Share of wallet of all Accounts.</li><li>Achieve Budgeted Sales value, volume and ASP’s for the allotted markets</li><li>Achieve Budgeted business growth in New products in the allotted markets</li><li>Achieve Budgeted DSO’s for the allotted Accounts.</li><li>Customer retention rate</li><li>Net Promoter Score</li></ul> Key Interfaces: Internal Interfaces <ul><li>Sales &amp; Marketing</li><li>CEOs Office</li><li>Strategy</li><li>SCM</li><li>Operations</li><li>Quality</li><li>Development &amp; Technology</li><li>Finance</li><li>HR &amp; Admin&nbsp;&nbsp;&nbsp;</li></ul> External Interfaces: <ul><li>Customers</li><li>Agents/ Distributors</li><li>Corporate Marketing</li></ul> Requirements: Education: <ul><li>Bachelors Degree preferably in Business Administration, Marketing, Engineering or a related field.&nbsp;&nbsp;&nbsp;&nbsp;</li><li>Master’s Degree in Business Administration (MBA) with a specialization in Sales, Marketing, or Strategy would be deisred.</li><li>OR Relevant experience or certifications in Key Account Management, Sales Leadership, or Market Analysis (e.g., Certified Key Account Manager, Sales Management Certification).</li></ul> Experience: <ul><li>5–8 years of experience in Sales or Business Development, preferably in the packaging, manufacturing, pharmaceutical, or related B2B sectors. Familiarity with the markets, including regional business practices and customer preferences.</li><li>Experience in techno-commercial roles, with the ability to understand and communicate technical product specifications and benefits and demonstrated success in handling cross-border sales and navigating regulatory requirements in the assigned regions would be deisred.</li><li>Experience working with multi-cultural teams and customers across the assigned territories.</li></ul>

Responsibilities: <ul><li>Strategic Planning and Execution</li><li>Design and implement pricing strategies tailored to accounts and key customers.</li><li>Identify and prioritize market-focused products to drive value growth for the organization.</li><li>Develop a deep understanding of the needs and expectations of accounts and key customers.</li><li>Craft a Key Account Management strategy aligned with our client Packaging Materials overarching business objectives.&nbsp;</li></ul> Core Functional Responsibilities <ul><li>Develop the annual budget in collaboration with sales leaders, ensuring achievement of targeted sales volume and value.</li><li>Plan and conduct proactive customer visits and meetings to deepen understanding of customer requirements and build strong relationships.</li><li>Provide timely techno-commercial information and clarifications to address customer inquiries.</li><li>Regularly update customers on new product offerings and enhancements in the product range.</li><li>Devise alternative solutions to address supply challenges for specific orders.</li><li>Identify and pursue potential business opportunities, converting them into sustained revenue streams.</li><li>Implement corrective and preventive actions to resolve and avoid customer complaints effectively.</li><li>Recommend pricing strategies tailored to customer needs, ensuring approval and seamless implementation.</li><li>Gather and analyze customer and competitor data, including pricing, credit terms, volumes, business share, and quality assessments.</li><li>Maintain the budgeted ASP (Average Selling Price) to achieve the overall contribution outlined in the budget. Internal Process</li><li>Develop detailed, customer-specific plans to achieve targeted price realization and contribution. Ensure timely collection of payments from customers in alignment with agreed terms.</li><li>Coordinate with the Group Sales team to promote combo deals, fostering deeper customer relationships.</li><li>Work closely with internal stakeholders across our client Films &amp; Foils to ensure seamless fulfillment of customer requirements.</li></ul> Key Result Areas <ul><li>Improvement in Share of wallet of all Accounts.</li><li>Achieve Budgeted Sales value, volume and ASP’s for the allotted markets.</li><li>Achieve Budgeted business growth in New products in the allotted markets.</li><li>Achieve Budgeted DSO’s for the allotted Accounts</li><li>Customer retention rate.</li><li>Net Promoter Score.</li><li>Improvement in Share of wallet of all Accounts.</li><li>Achieve Budgeted Sales value, volume and ASP’s for the allotted markets.</li><li>Achieve Budgeted business growth in New products in the allotted markets.</li><li>Achieve Budgeted DSO’s for the allotted Accounts.&nbsp;</li><li>Customer retention rate.</li><li>Net Promoter Score</li></ul> Requirements: <ul><li>Bachelors Degree preferably in Business Administration, Marketing, Engineering or a related field.</li><li>Master’s Degree in Business Administration (MBA) with a specialization in Sales, Marketing, or Strategy.</li><li>OR Relevant experience or certifications in Key Account Management, Sales Leadership, or Market Analysis (e.g., Certified Key Account Manager, Sales Management Certification).</li><li>5–8 years of experience in Sales or Business Development, preferably in the packaging, manufacturing, pharmaceutical, or related B2B sectors.</li><li>Familiarity with the markets, including regional business&nbsp;</li><li>Experience working with multi-cultural teams and customers across the assigned territories.</li><li>Experience in techno-commercial roles, with the ability to understand and communicate technical product specifications and benefits.</li><li>Demonstrated success in handling cross-border&nbsp;</li></ul> Other Locations: <ul><li>United Kingdom (LONDON), IRELAND, NETHERLANDS, BELGIUM, LUXEMBOURG</li></ul>

Responsibilities: <ul><li>Quality point of contact for assigned Southeast Asia customer accounts.</li><li>Provide the Voice of the Customer feedback to product management, product engineering and manufacturing locations for characteristics that can become quality or application risks to the customer.</li><li>Manages Quality / Reliability interactions with the customer, including regular communication and escalations.&nbsp;</li><li>Provides technical support in evaluating products from a quality and reliability standpoint.</li><li>Leads cross-functional problem-solving teams to investigate quality issues and minimize customer impact, Company PPM, cost of poor quality and drive timely resolution.</li><li>nfluences without authority in efforts to achieve 5D/8D response time within 10 business days or less.&nbsp;</li><li>Responsible for coordinating and ensuring completion of customer quality requested activities across design and manufacturing. This includes coordinating globally for all sites, factories, and associated teams within company.&nbsp;</li><li>Carries out the customer quality improvement strategy.</li><li>Ensures compliance to company quality policies and procedures related to customer requirements.</li><li>Partners closely with sales, engineering, and operations to ensure organizational alignment regarding setting targets and achieving quality objectives for our customers.</li><li>Partners with engineering and sales to establish trust with our customers by sharing our DND strategic quality roadmap as well as resolving problems in a timely manner.</li><li>Regularly conducts reviews with key customers regarding DNDs quality &amp; delivery performance.</li><li>Drives systemic corrective action and continual improvement for customers through training and implementation and use an array of quality improvement tools.</li><li>Regularly reports to management on the overall performance and effectiveness of the assigned strategic customer account.</li><li>Manage quality issues or inquiries for parts in assigned Global Product Lines. The parts may be made at a company facility or at a sub-tier supplier.&nbsp;</li><li>Supports the MRB team functions for disposition of non-conforming products.</li><li>Visit local customers and travel within Southeast Asia to customer locations to review company product and application as it is being used by the customer and to foster productive working relationships.</li><li>Conduct audits at manufacturing sites and attend to customer audits.&nbsp;</li><li>Work with DC, Planner, Sales &amp; CCP on block stock &amp; RMA return.</li><li>Coordinate onsite sorting at customer site with Sales, Planner &amp; CCP.</li><li>Coordinate RMA request &amp; return with manufacturing.</li></ul> Requirements: <ul><li>Bachelor Degree in Engineering with technical focus.</li><li>5+ years minimum quality assurance experience working in a global capacity.</li><li>Preferred customer quality experience in the electronics industry.</li><li>Demonstrated ability to lead teams, forge strong internal relationships, and drive transformation globally.</li><li>Knowledge and application of quality system regulations (ISO 9000, 14000 and 18000).</li><li>Experienced in the use of Lean, Six Sigma, Kaizen, 8D and other advanced statistical methods including Design of Experiments (DOE), Statistical Process Control (SPC), and Process Capability (CpK) techniques.</li><li>Possesses strong leadership skills and executive level presence.</li><li>Self-motivated, efficient, ability to work with little or no supervision, and committed to a team approach.</li><li>Strong interpersonal, organization, and project management skills.</li><li>Ability to prioritize responsibilities in a fast-paced work environment.</li><li>May require travel to customers and other company locations, including overnight and multi-day trips.</li><li>Experience in core processes such as stamping, molding, plating and assembly preferred.</li></ul>

Responsibilities: Trade Compliance Activities in the BU: <ul><li>Execute trade operations and provide compliance oversight for the assigned BU to ensure compliance with import/export laws and regulations in UK, US &amp; Indian SCOMET Export Controls</li><li>Maintain trade operations and compliance activities in accordance with policies, procedures, and controls, in collaboration with&nbsp;</li></ul> key stakeholders throughout the BU: <ul><li>Act as a point of contact for BU stakeholders on trade-related matters.</li><li>Work with BU stakeholders and counsel to understand business changes and develop trade-related solutions/strategies and controls to ensure compliance</li><li>Maintain BU-level Key Performance Indicators (KPIs) and reporting to ensure efficiency and effectiveness of the operations</li><li>Partner with Trade Compliance Professionals and Stakeholders across the Enterprise</li><li>Partner with GTS Governance to monitor trade compliance regulatory and legislative changes, assess the potential impact to the BU, and determine the necessary actions and communications to the appropriate stakeholders</li><li>Work with GTS Governance teams to conduct trade compliance audits and oversee corrective action plans</li><li>Partner with GTS Governance to develop and administer effective trade compliance training as required throughout the region and organization&nbsp;</li><li>Ensure appropriate utilization of the GTS Operations Service Centre for product classification (import and export), restricted party screening, and duty savings compliance, and otherwise ensure proper country of origin determination, valuation, and admissibility</li><li>Work with the Operational Service Centres to identify, evaluate and administer opportunities to facilitate trade in a cost-effective and compliant manner (e.g. make use of applicable Free Trade Agreements, Duty Drawback, First Sale for Export, Foreign Trade Zones, etc.)&nbsp;</li><li>Establish and maintain relationships with internal functions, including corporate functions, to encourage awareness of global trade compliance issues, pro-actively identify trade risk and threats, and develop appropriate trade compliance controls</li></ul> Talent Development &amp; Leadership: <ul><li>Create a culture of engagement and performance in alignment with core values&nbsp;</li><li>Lead by example and act with empathy</li></ul> Requirements: <ul><li>Experience in UK, US &amp; Indian SCOMET Export Controls</li><li>SAP &amp; GTS experience</li><li>Customs Compliance experience</li><li>Management of a team</li><li>Success in the role requires strong analytical and creative problem-solving skills, highly developed oral and written communication skills, and the ability to work with interdisciplinary teams (internal and external) to drive issues and projects to conclusion.&nbsp;&nbsp;</li></ul> In addition, successful candidate will have the following qualifications, experience, and skills: <ul><li>Bachelors degree required (international business, supply chain, law, or related field)</li><li>3+ years’ experience in global trade compliance</li><li>Functional knowledge of import and export regulations and familiarity with customs practices in countries across the region</li><li>Proven ability to work with variety of business groups, including supply chain, legal, procurement and finance</li><li>Ability to foster teamwork and internal and external relationships</li><li>Excellent organizational habits and priority management&nbsp;</li><li>Customer focused with a commitment to quality</li><li>Travel may be necessary in fulfillment of responsibilities</li></ul>

Responsibilities: <ul><li>Lead the implementation and optimization of ServiceNow ITOM solutions, ensuring alignment with business objectives.</li><li>Design, configure, and maintain the CMDB, ensuring data accuracy and integrity.</li><li>Implement and promote the CSDM framework to standardize and enhance service management practices.</li><li>Collaborate with cross-functional teams to gather requirements, develop functional specifications, and deliver effective ServiceNow solutions.</li><li>Provide training and support to end-users and stakeholders on ITOM, CMDB, and CSDM functionalities.</li><li>Conduct regular audits and assessments of the CMDB to ensure compliance with industry standards and best practices.</li><li>Identify opportunities for process improvement and automation within ServiceNow.</li><li>Stay updated on ServiceNow releases and new features, recommending enhancements that benefit the organization.</li></ul> Requirements: <ul><li>Bachelor’s degree in Information Technology, Computer Science, or a related field.</li><li>Minimum 3 years of proven experience in implementing ServiceNow solutions, particularly in ITOM, CMDB, and CSDM.</li><li>Strong understanding of ITIL processes and frameworks.</li><li>ServiceNow certifications (e.g., Certified Implementation Specialist, ITOM) are highly desirable.</li><li>Excellent analytical and problem-solving skills.</li><li>Strong communication and interpersonal skills to effectively collaborate with technical and non-technical stakeholders.</li><li>Ability to manage multiple projects simultaneously and meet deadlines.</li></ul>

Responsibilities: <ul><li>Customer Management and Service Excellence: Act as the primary point of contact for assigned complex, high-priority accounts, ensuring consistent and reliable performance. Manage customer situations, including escalations, from order placement to order delivery while proactively identifying and resolving issues to enhance the customer experience.</li><li>Process Optimization and Problem Resolution: Analyze trends and conduct root cause analyses to address pricing discrepancies, OS&amp;D, and returns. Use tools like SAP, Microsoft Excel and Celonis to drive process efficiencies and implement continuous improvement initiatives.</li><li>Strategic Collaboration and Stakeholder Engagement: Partner with internal and external stakeholders, including supply chain, finance, sales teams, brokers, IT, and transportation carriers, to resolve logistical challenges and enhance the overall customer experience.</li><li>Performance Monitoring and Analytics: Use data-driven insights to evaluate and improve order management processes. Develop and present analytics-based recommendations to sales partners and customers, ensuring adherence to service-level agreements (SLAs) and key performance indicators (KPIs), and internal policies, including GAAP, SOX, and audit requirements.</li><li>Capability Building and Leadership: Lead special projects and continuous improvement initiatives to drive innovation within the order management process. Build individual skills through training and participate in pilots, system testing, and service rehearsals before implementing major changes.</li><li>Manage high-priority customer accounts, ensuring orders are processed correctly.</li><li>Analyze customer issues and provide solutions to prevent recurring problems.</li><li>Work closely with Sales &amp; Finance to resolve pricing, invoicing, and payment discrepancies.</li><li>Support continuous improvement projects and process automation.</li><li>Use SAP &amp; Celonis to track performance and identify trends.</li></ul> Requirements: <ul><li>Bachelor’s degree in Business Administration, Logistics, or a related field.</li><li>Proven ability to manage complex, high-priority accounts while building and maintaining strong relationships with internal and external stakeholders.</li><li>Proficiency in ERP systems (e.g., SAP) and Microsoft Office, with demonstrated ability to leverage data for trend analysis and process optimization.</li><li>Analytical and root cause analysis skills to identify and resolve challenges in order management processes.</li><li>Excellent verbal and written communication skills with the ability to present insights and lead cross-functional projects or initiatives.</li><li>Strong time management skills with the ability to manage competing priorities and consistently meet or exceed performance objectives.</li><li>Advanced English level is mandatory, as this role provides services to US.</li></ul>

Overview: <ul><li>This position will lead within operations both manufacturing and packaging teams in Somerset, NJ.</li><li>Reporting to one of the operation Managers, operation Supervisors lead teams in designated technology areas and product trains at the site, directs and coordinates the activities of department operators , conduct performance reviews, interact with support departments, and drive efficiencies initiatives within operations.</li><li>The Somerset, NJ site produces oral solid and liquid dosage form pharmaceuticals.</li></ul> Responsibilities: <ul><li>Will lead oral solid dosage form manufacturing and packaging teams as assigned.&nbsp;</li><li>First shift leader with start time 6:00 am to 2:00 pm (8 hr. - 5 days/week) or 5:45 am to 4:00 pm (10 hr, 4 days/week).&nbsp;</li><li>Discussion with Manager on the right fit and team needs.&nbsp;</li><li>Develop, recommend, and implement measures to improve production methods, equipment performance, and quality of product&nbsp;</li><li>Track production processing and material management in SAP&nbsp;</li><li>Daily metrics reporting such as variances in production, labor hours and downtime, track and report operator performance and attendance&nbsp;</li><li>Oversee completion of GPM records and standard operating procedures required within operations&nbsp;</li><li>Participate and develop plans for improving a safe work place and culture of identifying, reporting, and fixing unsafe conditions and behaviors within the site and our work teams.&nbsp;</li><li>Work with cross functional groups to accomplish objectives including finance, procurement, operations, supply chain, maintenance, facilities, technical services, security, quality assurance, and quality control as appropriate.&nbsp;</li><li>Under the direct supervision of a leader and able to communicate progress, needs, requirements, and issues effectively for assigned work for yourself and your teams.&nbsp;</li><li>Carry out all duties in accordance with Good Manufacturing practices (cGMP) and standard operations procedures.&nbsp;</li></ul> Requirements: Qualifications and Education Requirements: <ul><li>Associates degree or higher preferred&nbsp;</li><li>5+ years of pharmaceutical packaging OR manufacturing experience&nbsp;</li><li>2+ years’ experience leading/supervising in a manufacturing environment&nbsp;</li><li>Working knowledge of SAP or another ERP system&nbsp;</li><li>Excellent written communication skills</li></ul>

Role Description: <ul><li>Position Overview: We are seeking a skilled and detail-oriented Electrical/Controls Technician to join our pharmaceutical operations team. </li><li>The successful candidate will be responsible for the installation, maintenance, troubleshooting, and repair of electrical control systems used in pharmaceutical manufacturing and packaging processes. </li><li>This role is critical to ensuring operational efficiency, product quality, and compliance with regulatory standards.&nbsp;</li></ul> Responsibilities:&nbsp; Installation and Maintenance:&nbsp; <ul><li>Install and maintain electrical control systems, PLCs (Programmable Logic Controllers), HMIs (Human-Machine Interfaces), and SCADA systems.&nbsp;</li><li>Perform routine preventive maintenance on electrical systems to minimize downtime and ensure continuous operation.&nbsp;</li><li>Test and validate electrical control systems during commissioning and upgrades.&nbsp;</li></ul> Troubleshooting and Repairs:&nbsp; <ul><li>Diagnose and resolve malfunctions in electrical systems, instrumentation, and automation equipment.&nbsp;</li><li>Utilize diagnostic tools, schematics, and software to identify root causes of system failures.&nbsp;</li><li>Repair or replace faulty components, including relays, sensors, actuators, and circuit boards.&nbsp;</li></ul> System Optimization:&nbsp; <ul><li>Program, configure, and optimize PLCs, HMIs, and VFDs (Variable Frequency Drives) to improve system performance and efficiency.&nbsp;</li><li>Assist in the design and implementation of new electrical control systems for process improvements and new projects.&nbsp;</li><li>Conduct system performance tests to ensure compliance with specifications and regulatory requirements.&nbsp;</li></ul> Documentation and Compliance:&nbsp; <ul><li>Maintain accurate documentation of electrical control systems, including wiring diagrams, and maintenance logs.&nbsp;</li><li>Ensure all activities comply with GMP (Good Manufacturing Practices), FDA, and other regulatory guidelines.&nbsp;</li><li>Participate in audits and provide technical expertise regarding control systems and maintenance records.&nbsp;</li></ul> Safety and Training:&nbsp; <ul><li>Adhere to safety protocols and ensure that all electrical work complies with NFPA, OSHA, and company standards.&nbsp;</li><li>Conduct risk assessments for electrical systems and implement appropriate safety measures.&nbsp;</li><li>Provide technical training to maintenance personnel on electrical systems and best practices.&nbsp;</li></ul> Collaboration:&nbsp; <ul><li>Work closely with engineering, production, and quality assurance teams to ensure electrical systems support manufacturing requirements.&nbsp;</li><li>Communicate effectively with equipment vendors and contractors for system upgrades and troubleshooting.&nbsp;</li></ul> Requirements: <ul><li>Education: Associate’s degree in electrical engineering, electronics, or a related field.&nbsp;</li><li>Experience: Minimum of 3-5 years in electrical controls, automation, or instrumentation, preferably in a pharmaceutical or regulated industry.&nbsp;</li><li>Technical Skills: Proficiency in PLC programming (e.g., Allen-Bradley, Siemens).&nbsp;</li><li>Strong understanding of electrical schematics, control wiring, and instrumentation.&nbsp;</li><li>Familiarity with SCADA systems and industrial networks.&nbsp;</li><li>Knowledge of GMP and regulatory standards in the pharmaceutical industry.&nbsp;</li></ul> Certifications: <ul><li>Relevant certifications (e.g., Journeyman Electrician, ISA Technician Certification) are a plus.&nbsp;</li></ul> Key Competencies:&nbsp; <ul><li>Analytical problem-solving skills with attention to detail.&nbsp;</li><li>Ability to work independently and as part of a team.&nbsp;</li><li>Excellent communication and documentation skills.&nbsp;</li><li>Commitment to safety, quality, and regulatory compliance.&nbsp;</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>

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Product Manager (Pharma)

Area Sales Manager

Area Sales Manager - Europe

Customer Quality Engineer

Team Lead - Global Trade Compliance

ServiceNow Consultant

Customer Service Advisor (Senior Analyst)

Operation Supervisor

Electrical/Controls Technician

Lead Quality Specialist - Investigator

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Location

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80 conduct warm call Jobs found

Product Manager (Pharma)

Area Sales Manager

Area Sales Manager - Europe

Customer Quality Engineer

Team Lead - Global Trade Compliance

ServiceNow Consultant

Customer Service Advisor (Senior Analyst)

Operation Supervisor

Electrical/Controls Technician

Lead Quality Specialist - Investigator

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

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