What you will do
- 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
- Ensure the proper execution of the qualification and validation activities with respect of the GSK validation methodology to maintain the validated status of automated and computerised systems
- Ensure QA activities on quality systems (CAPA, Deviation, Change Control, …) related to automated and computerised systems.
- Support team and management during internal and external audits
- Experience, Knowledge & Soft Skill Requirements
What you need
- 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, …)
Soft Skills
- Autonomy
- Critical mind
- Team player
- Good communication skills.
- Good analytical skills; ability to investigate and ask questions, on the shopfloor.
- Autonomous, Rigorous, Structured, Systematic.
- Ability to work in team, multidisciplinary environment; lead and impact cross-functional team members.
- Quality oriented.
What we offer
- We offer you a challenging job in an autonomous and growing Belgian tech company focused on engineering services
- We are committed to helping you achieve your potential, to accompany you in your personal growth and through career opportunities
- We attach great importance to entrepreneurship, passion, and solidarity. Quality for our customers and growing employees are our top priority.
- We offer an attractive salary with various fringe benefits (package)