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Quality Release Officer

Voor mijn key client in Oss zoek ik een Quality Release Officer in Oss.
Belangrijk is:
- QA Achtergrond / ervaring (minimaal 1 jaar)
- HBO / WO opleiding

De functie staat open tot en met eind van het jaar, verlenging is mogelijk. Zie hieronder de functieomschrijving.


Qualifications:
Experience should be in the pharmaceutical/chemical industry or government drug-regulatory agency with a working knowledge of cGMP regulations. Effective communications (oral/written) and interpersonal skills are necessary.


Responsibilities:
The Quality Auditor conducts routine audits of data, information, procedures, equipment and systems (including computer systems), and/or facilities to ensure the compliance with SOPs and GMPs and worldwide regulations. Review and approve production and analytical documentation accompanying the release of API, Safety Assessment or clinical supply lots (bulk and packaged) to ensure conformance to appropriate regulatory requirements. In addition, the Auditor communicates and resolves audit comments with client areas. Under supervision, or as part of a team, perform audits or inspections of assigned areas or systems to assess compliance with regulatory and Company standards. Issue reports summarizing deficiencies and work with areas to execute remedial action. Notify appropriate management of inspection result. Position will receive direction and support.

Neem gerust contact op voor meer informatie: s.kolks(at)realstaffing.com of bel mij op 020 522 1588