QA Release Associate for Imported Medicinal Product

Il y a 2 mois

LouvainlaNeuve, Belgique Zoetis Temps plein

locations- Louvain-la-Neuve- time type- Full time- posted on- Posted Today- job requisition id- JR00013663- Zoetis Louvain-la-Neuve is a manufacturing site but is also a major actor in the importation of veterinary medicinal products in Europe.
- Position summary
- Assist the Qualified Person in the release of veterinary finished products imported by Zoetis Belgium sa for European markets in compliance with the registration dossier and within relevant cGMP/GDP guidelines (annex 16 and annex 21).
- Communicate with the distribution centre and with Zoetis Global supply chain dept
- Position responsibilities
- Check retention samples for compliance with the expected packaging material.
- Review temperature profiles and shipping conditions.
- Prepare and review the batch documentation of products (certificate of analysis, certificate of compliance, deviation report ) in order to submit the certification of the batch to the Qualified Person.
- Manage any quality/regulatory deviation with either Supply chain and logistics colleagues or with Quality representatives of the manufacturing/testing sites.
- Manage the archiving process for batch records and retention samples
- Participate in investigations related to the testing performed on site.
- Ensure a full compliance with the Annex 16 and Annex 21 of the cGMP.
- Ensure the Product Quality Review
- Take proactive ownership and the responsibility to release products in a timely manner.
- Continuously seek opportunities to improve existing systems, processes, and performance.
- Requirements
- A first experience in pharma health industry and preferably in a release position
- Knowledge of cGMP/GDP
- Proven ability to work cross-functionally with other departments
- Ability to work independently and in team
- Ability to manage multiple projects simultaneously and prioritize work, goals and tasks Written proficiency in English
- Quality oriented

Full time
- OR:

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