Consultant assignment (contract / freelance), on-site in Liege (Belgium), GMP aseptic fill and finish environment (Cytiva SA25 robotic isolator, single-use systems, fully digitalized / paperless QMS and batch records).
Start date: ASAP. Mission duration: 4 months.
Language: working English required; French is a plus.
Consulting partners: please send candidate profiles to [email protected].
Key responsibilities
- Apply and maintain the Pharmaceutical Quality System (PQS) per GMP/GDP and applicable regulations.
- Review and approve GMP documentation (SOPs, work instructions, protocols, reports, batch records).
- Manage deviations, CAPAs and change controls: assessment, investigation support, follow-up and closure.
- Support qualification / validation review and approval.
- Contribute to risk assessments and to the Contamination Control Strategy.
- Manage supplier and material quality (qualification, complaints, quality agreements support).
- Support computerized system validation (CSV): GxP system classification, validation deliverables (URS, IQ/OQ/PQ), periodic review, audit trail and access reviews.
- Ensure data integrity (ALCOA+) and compliance with Annex 11 / 21 CFR Part 11 across computerized systems.
- Support customer audits and regulatory inspections (preparation, hosting, follow-up).
- Track quality KPIs and escalate quality issues to management.
Required profile
- Diploma in pharmacy, chemistry, biology, bio-medical sciences or related field.
- 5+ years of experience in QA in the pharmaceutical industry, ideally sterile manufacturing.
- Strong knowledge of EU GMP (Annex 1), GDP and data integrity (ALCOA+) expectations.
- Hands-on experience with deviation, CAPA and change control management.
- Computerized System Validation (CSV) competencies: GAMP 5, Annex 11, 21 CFR Part 11, validation lifecycle (URS, IQ/OQ/PQ).
- Experience supporting audits and regulatory inspections.
- Experience with an eQMS system (e.g. Scilife or similar).
- Rigorous, structured, and able to work autonomously with cross-functional teams.