QA Officer

A large scale pharmaceutical and life sciences manufacturing environment focused on high quality biological and chemical production. The organisation operates under strict GMP standards and supports continuous improvement across complex production operations.

The QA Officer plays a key role within Quality Operations, ensuring that all production activities comply with cGMP requirements. The role supports manufacturing from receipt through to distribution and acts as a quality partner to production teams. You will work closely with Qualified Persons and operational stakeholders to safeguard product quality and compliance.

• Advise on and approve equipment installation, qualification and validation protocols and reports as a subject matter expert
• Support deviation investigations including root cause analysis, approval of studies, conclusions and CAPAs
• Review and approve standard production documentation, protocols and master batch records for production and filling
• Assess and approve process changes through change control procedures
• Conduct routine audits of data, procedures, equipment, systems and facilities to ensure compliance with SOPs and GMPs
• Review and approve production and analytical documentation for release of API, clinical supply or safety assessment lots
• Communicate audit findings, resolve comments with stakeholders and issue reports summarising deficiencies
• Support inspections and audits under supervision or as part of a team and elevate results to management

• At least HBO level education, preferably in Life Sciences, Pharmacy, Biology or Laboratory related studies
• Experience in the pharmaceutical or chemical industry or within a drug regulatory agency
• Hands on experience with biological and or pharmaceutical chemical production processes
• Strong working knowledge of GMP and cGMP regulations
• Excellent command of Dutch and English, both written and spoken
• Strong communication and interpersonal skills
• Ability to advise proactively and support change
• Structured and detail oriented approach to quality compliance

• Possible 1 day from home after 6 months