Validation – Senior
Contracting – Brabant Wallon
Your responsibilities ?
The mission consists of:
- Ensuring quality for the validation part in the relevant projects (e.g., PUPSIT, RTU, …)
- Conducting QA Oversight of validation activities
- Actively participating in defining validation strategies in collaboration with project/validation teams and in compliance with GS requirements
- Reviewing and approving all documentation related to validation (URSFMEA-LRA-CRA-DQ-IOQ-PQ-Leveraging Reports)
- Participating in deviation investigations and troubleshooting
Key responsibilities:
- Reviewing and approving all documentation related to the projects under their responsibility: validation plans, validation summary reports, URS, FMEA, Leveraging Reports, IQOQ protocols and reports, PQ protocols and reports, CRA, LRA
- Actively participating in the project and process design phase to understand the project and establish an appropriate implementation and validation strategy
- Establishing workload planning based on project schedules
- Ensuring the chronological and logical execution of validation activities
- Actively participating in project follow-up meetings, troubleshooting, and addressing various issues to anticipate validation impacts or risks and contribute to developing solutions
- Ensuring QA Oversight of implemented methods
- Providing coaching/transferring/handover of knowledge related to different projects
Your profile ?
- Engineer or university degree in biotechnology, agronomy, chemistry, pharmacy, etc.
- Minimum of 5 years of experience in an aseptic laboratory/industry, quality, or production environment
- Experience in a regulated environment such as cGMP
- Experience in industry validation; and in specific documents: URS, FMEA, Leveraging Reports, LRA (L=Leachables), CRA (C=Compatibility)
- Knowledge of IPV (In-Process Verification) and PA (Proces Analytical Technology) processes is a plus
- Advanced knowledge of aseptic technologies, closed systems
- Experience as a QA Validation professional
- Knowledge of GMP and aseptic environments
Our offer ?
We offer you a permanent contract and an attractive salary package. You'll also benefit from the opportunity to develop personally and professionally through in-house training.
If you're interested, don't wait any longer!
