Commissioning & Qualification > Quanta part of QCS Staffing > Joboolo BE :
Company : Quanta part of QCS Staffing Location : Brussels Brussels From : Talent BE
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/ propertyRequirements:
5+ years of hands-on, end to end experience with SINGLE USE EQUIPMENT in International CAPEXC&QExtensive 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 requirementsIf this role is of interest to you, please apply now! #LI-CB1 Quantapart of QCS Staffing BrusselsBrussels
