Senior Quality Officer QMS

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.

Acquisitie wordt niet op prijs gesteld. Prothya aanvaardt geen ongevraagde hulp van bureaus voor deze vacature. Toegestuurde cv's (in welke vorm dan ook) door bemiddelingsbureaus aan enige medewerker van Prothya zonder geldige schriftelijke zoekopdracht, worden gezien als eigendom van Prothya waarvoor op geen enkele wijze een vergoeding verschuldigd is.