Open role
Senior Quality Officer QMS
Prothya Biosolutions Netherlands B.V.
What you'll do
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
What you'll bring
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's on 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.