Quality Assurance Specialist

Quality Assurance Specialist – Almere – Onsite

Als u geïnteresseerd bent om op deze vacature te solliciteren, zorg er dan voor dat u voldoet aan de volgende, hieronder vermelde vereisten.

A leading pharmaceutical excipient manufacturer in Almere is seeking a Quality Assurance Specialist to strengthen its QA team. This is an excellent opportunity for someone with experience in GMP‑regulated environments to take ownership of quality systems and contribute to continuous improvement within a global business.

Key Responsibilities

• Quality systems oversight: Maintain and improve the site QMS, ensuring compliance with GMP, EXCiPACT, ISO 9001, and customer requirements.
• Document control: Review, revise, and approve SOPs, specifications, and quality records, keeping documentation accurate and audit‑ready.
• Product release: Support batch disposition by reviewing records, test results, and supplier documentation to ensure compliance before release.
• Change management: Coordinate site change controls, impact assessments, and approvals, ensuring effective implementation and closure.
• Investigations: Lead deviation, non‑conformance, and supplier quality investigations, driving root cause analysis and CAPA activities.
• Validation support: Coordinate validation protocols, reports, and documentation, ensuring timely execution and compliance.
• Audit readiness: Maintain inspection readiness, support internal/external audits, and promote a culture of compliance and continuous improvement.

Requirements

• Degree in Pharmaceutical Sciences, Chemistry, Biology, Engineering, or related discipline.
• Experience in QA within pharmaceuticals, excipients, medical devices, food, or other regulated industries.
• Strong knowledge of GMP, GDocP, Data Integrity (ALCOA+), and QMS processes.
• Experience with document control systems, audits, validation, and CAPA management. xgiwjmb
• Excellent communication, organizational, and stakeholder management skills.