QA Validation
Wavre – Contracting
The Responsibilities
- Ensure QA oversight in validation activities (IQOQ / PQ / PV…)
- Review/Approve the validation documentation regarding the GMP requirements and the GSK Vaccines procedures
- Ensure that production practice are aligned with validation conclusion
- Attend all project meetings as QA validation representative
- Ensure timely escalation to Management of critical issues during validation
- Contribute to the deviation process providing QA oversight and approving deviation for deviations related to validation activities and/or impact of manufacturing deviations to validation activities
- Pro-actively identify potential quality and compliance risks and manage these risks through the risk register and quality plan process
- Work in autonomy with GSK supervision/coaching
- To define the validation strategies through the change control process
- To write and implement some validation documentation (Validation Plan, Validation Summary Report, Risk Assessment, Gap Analysis , Periodic review ….)
- To ensure the correct application of the validation quality systems in the field and to define improvement plan as required
- To support the production, QA and technical service teams in the implementation of the validation activities.
The skills and Knowledge Requirements
- Former relevant industrial experience related to the requested seniority in Validation and QA in a biopharmaceutical industry.
- Knowledge of GMP / CFR / Eudralex …
- Knowledge of different regulations and GSK standards related to validation activities (VP, VSR, IOQ, VSR, PVR)
- Knowledge of packaging activities
- Knowledge of KNEAT (electronical validation system), MADB (Alarm management database), SAP
Our Offer
Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We'll be your career partner every step of the way.
