Job Description Senior Quality Assurance Specialist
Client: Teva Pharmaceuticals
Location: Swensweg 5, 2031 GA Haarlem, Netherlands
Work Mode: Fully Onsite
Duration: 3 Months
Monthly Salary Range: 5,062 6,327
Grade: 12
About the Role
Teva is seeking an experienced Senior Quality Assurance Specialist to support pharmaceutical manufacturing operations at its Haarlem facility in the Netherlands. The successful candidate will provide technical quality assurance guidance, ensure compliance with Good Manufacturing Practice (GMP), and support the resolution of complex production and quality-related issues.
This role requires strong hands-on experience in pharmaceutical quality assurance, deviation management, root cause analysis, Corrective and Preventive Actions (CAPA), and manufacturing quality systems. The candidate will work closely with Production, Quality Assurance, Process Teams, Qualified Persons (QPs), and other stakeholders to maintain product quality, regulatory compliance, and operational excellence.
Key Responsibilities
1. Quality Assurance & GMP Compliance
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Provide technical QA guidance to pharmaceutical manufacturing and production teams.
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Ensure manufacturing activities comply with GMP requirements, approved procedures, and established quality standards.
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Monitor manufacturing processes and identify potential quality and compliance risks.
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Assess quality-related issues and recommend appropriate production actions within delegated authority and approved procedures.
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Support bulk manufacturing, packaging, and other related production activities.
2. Deviation Management & Investigations
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Investigate, document, assess, and close production deviations in accordance with established quality procedures.
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Conduct structured Root Cause Analysis (RCA) to identify underlying causes of quality incidents.
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Investigate product complaints and other product-quality issues.
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Develop, implement, monitor, and follow up on CAPA plans to prevent recurrence.
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Ensure investigations are evidence-based, adequately documented, and completed within required timelines.
3. Documentation & Quality Systems
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Review and update Standard Operating Procedures (SOPs), where required.
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Review Batch Manufacturing Records (BMRs), production records, and protocols for completeness, accuracy, and compliance.
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Review validation protocols and support validation-related activities.
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Assess and manage change controls in accordance with established quality systems.
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Maintain documentation integrity, traceability, data integrity, and audit trails.
4. Audits, Compliance & Continuous Improvement
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Support compliance investigations, audit responses, and the closure of audit observations.
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Implement quality improvements arising from deviations, audit findings, and compliance reviews.
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Identify opportunities to improve manufacturing processes, methods, products, and technologies.
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Participate in initiatives to optimise production efficiency without compromising product quality or GMP compliance.
5. Stakeholder Collaboration & Technical Guidance
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Collaborate with Production, QA, Qualified Persons (QPs), Process Teams, and other cross-functional stakeholders.
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Provide technical guidance and quality-related training to production personnel.
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Analyse quality trends, evaluate risks, interpret investigation findings, and provide sound recommendations.
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Communicate quality issues, investigation outcomes, and recommendations clearly to relevant stakeholders.
Educational Qualifications
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A bachelor's degree in Pharmacy, Pharmaceutical Sciences, Chemical Engineering, Life Sciences, or a related discipline, combined with several years of relevant experience; or
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A master's degree in a relevant scientific or technical discipline.
Required Experience & Technical Skills
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Relevant experience in pharmaceutical quality assurance, preferably within pharmaceutical production or manufacturing.
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Strong working knowledge of GMP requirements and pharmaceutical quality management systems.
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Hands-on experience in deviation management and quality investigations.
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Practical knowledge of Root Cause Analysis (RCA) methodologies.
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Experience developing, implementing, and monitoring CAPA plans.
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Experience with change control, audit support, and compliance investigations.
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Experience reviewing SOPs, Batch Manufacturing Records, production documentation, and validation protocols.
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Strong analytical, problem-solving, and risk-assessment capabilities.
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Excellent written and spoken English communication skills.
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Ability to provide technical guidance and work effectively in a demanding manufacturing environment.
Preferred Qualifications
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Experience or working knowledge of aseptic pharmaceutical manufacturing.
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Experience supporting bulk manufacturing and packaging operations.
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Experience implementing continuous improvement initiatives within pharmaceutical quality systems.
Work Location & Availability
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The position is fully onsite at Teva's Haarlem facility in the Netherlands.
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Candidates must be available to work onsite for the assignment duration of three months from the agreed start date.
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Candidates should be able to meet the client's requirements regarding availability, compensation, and onsite working arrangements.
Ideal Candidate Profile
The ideal candidate is a hands-on pharmaceutical QA professional with strong manufacturing experience and the ability to independently investigate quality issues, identify root causes, implement effective CAPAs, and provide practical quality guidance to production teams.
Candidates with general laboratory Quality Control (QC) experience alone, without sufficient pharmaceutical QA and manufacturing experience, may not be suitable for this position.
Application Requirements
Interested candidates should submit an updated CV highlighting their pharmaceutical manufacturing experience, GMP knowledge, deviation investigations, RCA, CAPA, change control, audit experience, and relevant documentation review expertise.
