Operational QA Oversight for Formulation for a Pharmaceutical Company

WE ARE LOOKING FOR A OPERATIONAL QA OVERSIGHT FOR FORMULATION FOR A BIG PHARMACEUTICAL COMPANY IN WAVRE.

YOU WILL BE THE SUPPORT TO THE OPERATIONAL QA SUPERVISOR.

KEY RESPONSIBILITIES

ENSURE:

- Deviations, complaints, change controls, CAPA, are reviewed and handle it in a timely manner with the right quality oversight
- Batches of the intermediate product related to the area of responsibility are released in a timely manner
- Quality oversight of validation activities
- A dequately and timel y escalated critical topics to higher management
- Represents QA in all operational meetings related to the area of responsibility

PREREQUISITES

EDUCATION : University Degree or equivalent

SPECIFIC SKILLS:

Good understanding of:

- o current Good Manufacturing practice (cGMP)
- o Supply Chain processes
- o Manufacturing
- Good interpersonal relationship

Knowledge:

- Management skills: Deviation management, CAPA management, complaints management
- Experience: Release and/or validation

Experience:

- At least 2 years in QA role (!) within a pharmaceutical industry, preferably in a sterile manufacturing company & (+) 3 years in production/QA role
- Someone already having access to GSK SAP deviation system (should start very quickly)
- Experience of cGMP
- Experience within aseptic facility