QA associate (temporary) - Johnson And Johnson - Antwerp - Wizbii

QA associate (temporary)

  • Par Johnson And Johnson
  • CDD
  • Antwerp (Belgium)
  • Qualité / Sécurité / Hygiène

Description de l'offre

Janssen Pharmaceuticals has been part of the Johnson & Johnson Group since 1961 and is one of the most innovative pharmaceutical companies in the world with more than 4000 employees in Belgium. Janssen develops treatment for a number of the major diseases and most complex medical challenges of our time, including mental disorders, neurological problems, infectious diseases, immunological conditions, cancer and cardiovascular and metabolic diseases.

The Clinical Supply Chain Manufacturing DP (CSC DP) organisation is part of the global Researh & Development organisation of Johnson & Johnson. This department is responsible for the delivery of Drug Product used in clinical trials for J&J.

For the quality organisation of CSC DP, we are searching for an enthousiastic colleague for the function of

QA associate

As QA associate, you support all QA CSC release activities relating to the dispensing, formulation, filling, packaging, QC testing and storage of Drug Products (DP) for use in clinical trials:

· you will be responsbile for the review of the batch records of orders internally produced in Clinical Supply Chain DP. This contains a review of the correctness and completeness of the batch record filled in by CSC DP
· you will be responsible for the review of the release documentation.
· you perform release of raw materials, consumables, packaging materials for use in DP production for clinical trials
· you support the management of quality issues/complaints

Ensure that deviations/complaints are timely and properly investigated such that the internal and external customer expectations are met.

· You support the QA CSC DP group in different task (e.g. SOP review) to get a broad overview of the CSC DP and QA CSC organisation

As QA associate, you will closely interact with the CSC DP groups in order to ensure timely releases and with other QA groups in order to ensure release of compliant product.

Profil recherché

Qualifications :

Critical competencies

·  Experience with GMP and/or other directives is an asset
·  Good verbal & written communication skills
·  Fluent in Dutch & English
·  Team player & flexible

Education & experience

·  Bachelor or Master degree in Chemical/Pharmaceutical sciences or equivalent based on experience.
·  at least 1 year of experience in a strongly regulated or GMP environment
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