Katarina Chalanska

CQV Downstream - Denmark - 12 Month ContractOur client, a global CDMO in pharmaceutical manufacturing, is recruiting for a CQV Downstream to join their new and exciting large-scale CAPEX investment programme. With a mission to provide process development and cGMP production in cell culture, microbial fermentation, and gene therapies, this is an outstanding opportunity make a genuine contribution to the biopharmaceutical industry. What you’ll do: Support generation of all CQV Downstream Documentation – FAT wraparounds, DQ, RTM, QRA, SAT/IOC and IOQ, including Final Reports.Generate DST Bridging document, ensuring full alignment with Process Science (PS) in relation to supply of CPPs and CQAs.Support CQV review, aligning with Transition Group in relation to review and approval of all Turnover Packages, both Vendor and Contractor Packages within the Process Equipment Support scope.Liaise with CQV SWAT Team in relation to punchlist closure both pre-M/C and during the CQV execution phase for all Process Equipment Support systems. What you’ll need: Downstream Equipment experience for biopharmaceutical manufacturing facilities. Experience with complex projects and working in or around operating facilities.Demonstrated proficiency communicating and collaborating at a variety of levels with customers, vendors, equipment suppliers and operations staff.Proven success working well in a team environment with flexibility to react to changing business needs. If this role is of interest, please apply now!#LI-KC1