Key Responsibilities
- GMP & Batch Release Activities
- Preparation of QP batch release documentation for intermediates, Drug Substances, Drug Products, and Finished Products
- Batch record review and approval
- Physical release of products in the warehouse
- Ensure overall QMS compliance related to QA operational tasks
- Supervise QA Officers or junior personnel where applicable
- Communicate with OMCL where required
Quality Management System (QMS)
- Assessment, review, and timely closure of deviations (minor, major, critical where applicable)
- Support extended Root Cause Analysis (RCA) using established methodologies
- Review and closure of OOS, OOL, and OOT investigations
- Support investigations related to Product Quality Complaints
- Handling of returned goods
- Review and follow-up of CAPAs
- Execute and follow up on change controls
Validation Support
- Review and approval of routine equipment validations
- Support validation activities where required
Inspections & Audits
- Act as Subject Matter Expert (SME) during internal audits and customer inspections
- Support regulatory audits and inspection readiness
- Present processes during audits where required
Training & Compliance
- Provide on-the-job training to QA Operations staff
- Support training in deviations, CAPA, and quality systems
- Write and review GMP procedures
- Review and approve GMP documentation (e.g., SOPs, Master Batch Records)
Documentation & Reporting
- Deliver quality data for monthly metrics and Quality Management Review
- Support Product Quality Review documentation
- Perform routine shopfloor QA oversight visits
People & Stakeholder Management
- Coach junior team members
- Act as project lead where applicable (SME)
- Support Quality Lead in stakeholder management
Requirements
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biotechnology, or related field
- Experience in GMP-regulated pharmaceutical or biotechnology environment
- Experience in QA Operations, Batch Release, or Quality Systems preferred
- Knowledge of EU GMP guidelines
- Strong analytical and problem-solving skills
- Experience with deviation management and CAPA processes
- Strong communication and stakeholder management skills
- Detail-oriented with strong documentation skills
- Ability to work independently and within cross-functional teams
What We Offer
- 8.33% end-of-year bonus and 8.33% holiday allowance.
- A personal training budget of €2,100 every three years to foster professional growth and development.
- Contribution to travel expenses from the first kilometer.
- Excellent accessibility by public transport and private parking available.
- A pension plan with Zorg & Welzijn, providing security for your future.
- A dynamic, safe, and challenging working environment with ample opportunities to grow, innovate, and learn, all while making a meaningful impact on the health of millions.
