Commissioning & Qualification
- Brussels
- Contract
- Commissioning, Qualification and Validation
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.5.2.8. /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
If this role is of interest to you, please apply now!
#LI-CB1
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
We have worked together with Quanta for seven years now and have always received a professional service. Quanta’s speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of Quanta’s people and their ability to deliver.
Global Pharmaceutical firm
I have always received a highly professional & personable service from the team at Quanta. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
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Chris
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