Commissioning & Qualification - Brussels, België - Quanta

Quanta

Geverifieerd bedrijf

Brussels, België

3 weken geleden

Geplaatst door:

Sophie Dubois

beBee Recruiter

Beschrijving

Senior C&Q Single Use Qualification SME - Brussels Month Contract

We are looking for an experienced Commissioning & Qualification for a fantastic 12-18 month contract based in Brussels.

You will be working with our client, a global biopharmaceutical organisation committed to improving the lives of people afflicted with neurological and immunological disease.

This is a superb opportunity if you are looking to advance your career in the field with a supportive and innovative company that will put you first.

Responsibilities:

Draft CQV documents, coordinate review and approval of applicable single use C&Q documents (QRA/DV/RTM/IOV/VSR) following approved single use VMP.
Act as C&Q Subject Matter Expert and Compliance for single use.

Ability to provide guidance and work with supplier and all C&Q activities from design to execution and to summary report approval.

Deep understanding of single use requirements such as Biocompatibility /Mechanical properties/ USP / E.P /Extractable/Leachable /Chemical compatibility/ Endotoxin /Sterilization/ Integrity/Particulates/ Packaging/labelling/Storage/ Expiration/ Release.

Deep understanding and experience of all types of single use verification and testing requirements in the field such as Pressure test/ Homogeneity/ Extractable/ Leachable/ Stability/ Chemical compatibility / Filling and mixing system (homogeneity)/ Sterilization validation/ Filter Integrity test/ property

Requirements:

5+ years of hands-on, end to end experience with SINGLE USE EQUIPMENT in International CAPEXC&Q
Extensive knowledge and demonstrated experience delivering single use verification for Pharmaceutical / Biotechnology projects including automationrelated aspects.
Strong understanding of a risk-based approach to commissioning and qualification within the biotechnology industry.
Knowledge of safety, GMP and environmental regulatory requirements

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