qa operations specialist in Zwijnaarde

posted:
location
Zwijnaarde, Oost-Vlaanderen
job type
Vast
reference number
RSBE437346
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job description

You ensure the QA oversight of the continuous validation activities. You take part in the implementation, the follow-up and the maintenance of the continuous validation plan. You define the validation strategies through the change control process. You write and implement some validation documentation. You will review and approve specific qualification and validation documentation (IQ, OQ, PQ, PV). You ensure the correct application of the validation quality systems on the field and define improvement plans if required. You support the production & technical services teams in the implementation of the validation activities. You take care of the adequate management of validation deviation and potentials CAPA. You participate to external audit as appropriate. Geïnteresseerd in deze vacature? Stuur je cv en motivatie naar hightechnics_gent@randstad.be

qualification

You have a Master degree in Sciences / Biological Engineering or equivalent through relevant experience. Since a number of years you already have relevant experience in a pharmaceutical / biotech: medical devices environment as Engineer, Validation expert or Quality Assurance. Experience in Pharmaceuticals is a strong asset. You have knowledge of GMP, 6 Sigma methodology and risk management tools like FMEA. You are familiar with documentation and writing validation documents. You are able to multitask and know to prioritize. You work independently and operate within a team concept. You can drive and motivate a team. You are a good planner and an analytical problem solver. You are a fluent communicator with a professional knowledge of Dutch and English (written and oral) and provide the necessary assertiveness.
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