Consultant - QA Officer

pbConsultant assignment /b (contract), on-site in Liege (Belgium), 1-2 days remote, GMP aseptic fill and finish environment (Cytiva SA25 robotic isolator, single-use systems, fully digitalized / paperless QMS and batch records). /ppbLanguage: /b working English required; French is a plus. /ph3Key responsibilities /h3ulliApply and maintain the Pharmaceutical Quality System (PQS) per GMP/GDP and applicable regulations. /liliReview and approve GMP documentation (SOPs, work instructions, protocols, reports, batch records). /liliManage deviations, CAPAs and change controls: assessment, investigation support, follow-up and closure. /liliSupport qualification / validation review and approval. /liliContribute to risk assessments and to the Contamination Control Strategy. /liliManage supplier and material quality (qualification, complaints, quality agreements support). /liliSupport computerized system validation (CSV): GxP system classification, validation deliverables (URS, IQ/OQ/PQ), periodic review, audit trail and access reviews. /liliEnsure data integrity (ALCOA+) and compliance with Annex 11 / 21 CFR Part 11 across computerized systems. /liliSupport customer audits and regulatory inspections (preparation, hosting, follow-up). /liliTrack quality KPIs and escalate quality issues to management. /li /ulh3Required profile /h3ulliDiploma in pharmacy, chemistry, biology, bio-medical sciences or related field. /lili5+ years of experience in QA in the pharmaceutical industry, ideally sterile manufacturing. /liliStrong knowledge of EU GMP (Annex 1), GDP and data integrity (ALCOA+) expectations. /liliHands-on experience with deviation, CAPA and change control management. /liliComputerized System Validation (CSV) competencies: GAMP 5, Annex 11, 21 CFR Part 11, validation lifecycle (URS, IQ/OQ/PQ). /liliExperience supporting audits and regulatory inspections. /liliExperience with an eQMS system (e.g. Scilife or similar). /liliRigorous, structured, and able to work autonomously with cross-functional teams. /li /ul