Do you have a scientific degree ? Do you have experience in a Computer System Validation role ? Are you autonomous, rigorous and quality oriented? Apply now !
Job Description :
For a multinational pharmaceutical company, we are looking for someone to fill our QA Computer System Validation role with interest in ensuring QA activities on quality systems (CAPA, Deviation, Change Control, ...) related to automated and computerized systems and supporting team and management during internal and external audits.
- Writing, reviewing and approving of validation plans and validation summary reports
- Reviewing and approving of design documentation (TCD, ERES, URS, DQ, ...)
- Reviewing and approving of qualification protocols and reports (IQOQ & PQ)
- Writing and reviewing of Periodic Review Reports (PR)
- Reviewing and approving of CSV specific documentation (inventory, ...)
- Reviewing of CVS specific SOP'S and Templates
- Ensuring the proper execution of the qualification and validation activities with respect of the validation methodology to maintain the validated status of automated and computerised systems
- Ensuring QA activities on quality systems (CAPA, Deviation, Change Control, ...) related to automated and computerised systems
- Supporting team and management during internal and external audits
- University (Master) degree in Sciences / Biological Engineering (e.g. Pharmacist / Master in Sciences / Bio Engineer)
- Experience in a computer systems validation role
- Fluency in French and English
- Certification in computer system validation or equivalent is a plus
- CGMP and specific regulations and guidelines applicable to computerized and automated systems (GAMP, Eudralex Vol 4 annex 11, 21 CFR part 11, …)
- Validation practices and guidelines (life cycle approach, ICH, ASTM E2500, …)
- ICT Skills (software, operating systems, hardware, etc.)
- SAP, MS OFFICE
- Autonomous, Rigorous, Structured, Critical thinking, Systematic
- Good communication and analytical skills; ability to investigate and ask questions, on the shopfloor.
- Ability to work in team, multidisciplinary environment; lead and impact cross-functional team members.
- Quality oriented
- Balanced salary package based on your skills and experience
- Hybrid model (remote/on-site)