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QA Officer – Packaging (Pharma)

Jefferson Wells Belgium · Braine-l'Alleud

CDI Mid 🇬🇧 English
equipment qualification process validation Product Quality Review (PQR) Continued Process Verification (CPV) SAP statistical analysis

Job description

About the role

We are seeking a QA Officer specialized in packaging to join a pharmaceutical client’s QA Field team. You will support manufacturing activities for combination products such as prefilled syringes assembled into autoinjectors and safety syringes, ensuring GMP compliance and quality oversight.

Key responsibilities

  • Act as QA Subject Matter Expert for packaging and combination product assembly processes.
  • Provide operational QA support on the shop floor, reviewing and approving deviations, CAPAs, investigations, complaints and Change Controls.
  • Oversee equipment qualification and validation activities, including review and approval of qualification protocols, cleaning validation and process validation reports.
  • Support risk management activities such as pFMEA and quality risk assessments.
  • Contribute to Continued Process Verification (CPV) and Product Quality Review (PQR) initiatives.
  • Participate in audits, market complaint investigations and quality improvement projects.
  • Collaborate closely with Production, QC, Regulatory Affairs, Supply Chain, Validation, Engineering and Procurement teams.

Required profile

  • Master's degree in a scientific discipline.
  • 3‑8 years of operational QA experience in the pharmaceutical industry.
  • Proven experience with quality systems covering deviations, investigations, CAPAs, complaints and Change Controls.
  • Hands‑on experience in equipment qualification and process validation (CSV, PQR, CPV, pFMEA).
  • Experience in a GMP‑regulated environment with strong interaction with production teams.
  • Knowledge of autoinjectors, safety syringes or medical‑device environments is a strong asset.
  • Fluent in French and English, both written and spoken.

Required skills

  • Equipment qualification
  • Process validation
  • Computerised System Validation (CSV)
  • Product Quality Review (PQR)
  • Continued Process Verification (CPV)
  • Process Failure Mode Effects Analysis (pFMEA)
  • SAP
  • Electronic Quality Management System (eQMS)
  • Statistical analysis

What we offer

  • Permanent contract as a consultant with an attractive compensation package.
  • Technical training and professional development opportunities.
  • Long‑term career growth within a leading pharmaceutical environment.

Questions fréquentes

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Le contrat proposé est un CDI basé à Braine-l'Alleud.

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Published 2 months ago

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Jefferson Wells Belgium

Braine-l'Alleud