Consultant - QA Officer

White Raven; Luik; Hybrid; EUR 70,000 - 95,000; Part time

Job summary

White Raven in Liege, Belgium seeks a Consultant QA specialist for a contract assignment on-site with 1-2 days remote. You will apply and maintain PQS per GMP/GDP, review GMP docs, support CSV validation and audits.

The role requires 5+ years in pharmaceutical QA, sterile manufacturing, EU GMP Annex 1, ALCOA+, and experience with deviations, CAPAs, change controls, and eQMS (Scilife or similar). Fluent English; French a plus.

Qualifications

• 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, URS/IQ/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.

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.

Skills

Pharma QA

Sterile manufacturing

EU GMP Annex 1

GDP

ALCOA+

Deviation management

CAPA

Change control

CSV (GAMP5)

21 CFR Part 11

Audits & inspections

eQMS (Scilife)

Cross-functional work

Education

Diploma in Pharmacy

Tools

Scilife

Job description

Consultant assignment (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).

Language: working English required; French is a plus.

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.