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Quality Assurance Specialist
Il y a 2 mois
locations- Louvain-la-Neuve- time type- Full time- posted on- Posted Today- job requisition id- JR00013235- Zoetis est le leader mondial de la santé animale, voué à accompagner ses clients et leurs entreprises. S'appuyant sur plus de 70 ans d'expérience en santé animale, Zoetis découvre, développe, fabrique et commercialise des vaccins et des médicaments vétérinaires, complétés par des produits de diagnostic et des tests génétiques, ainsi que par une gamme de services. Zoetis est au service des vétérinaires, des éleveurs d’animaux de rente et de ceux qui élèvent et prennent soin des animaux de compagnie et de rente, avec la vente de ses produits dans plus de 100 pays.
- Zoetis compte environ 11.000 collègues qui soutiennent nos activités dans les domaines des ventes, de la recherche et du développement, de la fabrication et de diverses fonctions mondiales. Lorsque vous rejoindrez Zoetis, vous aurez l’opportunité d’apprendre, de développer vos compétences et d’enrichir votre carrière de nombreuses manières : formation sur le terrain, travail sur des projets ambitieux ou simple apprentissage entre pairs et managers. Nous bâtissons notre prochaine génération de leaders en investissant dans le développement de nos collègues.
- Interested in end-to-end vaccines and other injectable drug products manufacturing process?
Looking for a more diversified activities challenge?
It’s time to expand your area of expertise
- Join the Team and become the swiss knives of the Quality Operation Department by supporting our Manufacturing, Engineering, Packaging and Quality controls departments.
- Mission
- Member of the Quality department, you ensure QA oversight of different engineering project such as new equipment, new aseptic suites, new packaging lines
- Next to this project support role, you are also responsible for a wide range of QA non-batch related topics across the end-to-end vaccines manufacturing processes such as periodic reviews, change management, deviations, trends monitoring and improvement projects.
- Key accountabilities
- For engineering projects
- Provide the QA oversight of qualification and/or validation projects, including visual inspection automated and semi-automated machine, autoclave validation and clean room construction/revamping (i.e., including review and approval of URS, VP, protocols, reports, VSR );
- Participate in investigations and CAPAs; perform the QA review and approval of selected deviations and change requests.
- For non-batch related QA activities
- Prepare and participate to regulatory inspections, including CAPA management.
- Plan, lead and report on internal and external audits.
- Provide the QA oversight for routine qualification / validation activities (HVAC, Sterilizers, Temperature controlled areas );
- Design and improve processes following Corporate Quality Guidelines.
- Support quality operations to ensure quality related commitments (CAPAs, change management, deviations) are handled in a timely manner;
- Maintain Site Support Documentation (e.g. Site Master File) ;
- Conduct periodic trending analysis of quality systems performance.
- Bring support to develop and/or report quality performance metrics.
- Who are we looking for?
- Excellent effective understanding of EU GMP and FDA cGMP; able to find pragmatic solutions to implement requirements in operations;
- University degree in a Science or Engineering discipline (e.g. Pharmacy, veterinary or Biological engineering);
- 5+ years of experiences in the sterile pharmaceutical industry, in a QA or production environment;
- Experienced in Qualification/validation following verification approach (ASTM E2500);
- Experienced in managing internal/external audits;
- Proficient in pharmaceutical quality management systems (e.g. deviations, CAPA and change control);
- Good communication skills (oral and written);
- Fluent in French; full professional proficiency in English.
- Why would you join the Quality Team?
- You will join a fast-growing company that has become the international market leader with a corporate culture heritage from Pfizer.
- By your unique background, experiences, knowledges, skills and ideas, you will bring your stone to building an ever-stronger Quality organization.
- You will benefit from a great autonomy in your work, with plenty of room for initiative, challenges and possibility to take ownership of your work.
Full time
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