For one of our clients, we are looking for a QA Validation Consultant
- Do you have a University degree?
- Do you have at least 2 years of experience in QA Validation within the pharmaceutical industry sector?
- Are you fluent in French with a good understanding of English?
Then, you might be the candidate we are looking for !
As a QA Validation Consultant for a project in filling, you provide QA support and oversight to validation activities within the Validation & Technical Service team of the company (10 persons). MPU filling and visual inspection.
- You provide a compliance expertise in validation
- You ensure QA oversight in validation activities (IQOQ / PQ / PV…)
- You review/approve the validation documentation regarding the GMP requirements and the GSK Vaccines procedures
- You ensure that production practice are aligned with validation conclusion
- You attend all project meetings as QA validation representative
- You ensure timely escalation to Management of critical issues during validation
- You 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
- You pro-actively identify potential quality and compliance risks and manage these risks through the risk register and quality plan proces
- You define the validation strategies through the change control process
- You write and implement some validation documentation (Validation Plan, Validation Summary Report, Risk Assessment, Gap Analysis , Periodic review ….)
- You ensure the correct application of the validation quality systems in the field and you define improvement plan as required
- You support the production, QA and technical service teams in the implementation of the validation activities.
- You have a university degree
- You have at least 2 years of experience in QA Validation within the biopharmaceutical industry sector
- You have knowledge of GMP / CFR / Eudralex …
- You have knowledge of different regulations and standards related to validation activites
- You have good interpersonal relationship skills
- You are fluent in French and have a good understanding of English
- You are problem solving and achievement oriented
- You are a good team player in order to succeed in each validation project and routine activities
+32 10 68 53 30