Commissioning & Qualification Engineer (Pharmaceuticals)

Job type:
on-site
Start:
10/2018
Duration:
3 Months Rollin
Place:
Sweden
Date:
09/14/2018
Country:
flag_no Sweden


Project description:

Fill Finish CQV Engineer
€70/hr
Sweden
Contract (3 Months Rolling)

A Fantastic new role has just opened at one of the world's leading pharmaceutical companies, working via a leading consultancy. Based on-site in Sweden, the client is offering the successful candidate the opportunity to join a hard-working team working on exciting projects in the pharmaceutical sector.
Responsibilities
  • Please Note vial filling experience is important Lead the FAT/SAT/IOQ activities through to operational and commercial batch release.
  • Process knowledge regarding the transportation of vials and the control of product within an IS0 5 isolator system.
  • Experience in leading GMP package review and approval process.
  • Led/support the product/process risk assessment activities.
  • Knowledge of supporting the design of an integrated EMS system.
  • Support development of CQV activities to meet ASTM E2500.
  • Knowledge of achieving 21 CFR part 211/annex 11 regulatory compliance.


Requirements
  • 5 + years Industry experience Familiar with client-side QMS/change control activities.
  • Experience in managing and supporting vendor activities onsite.
  • Great communicator and a team player. Experience with the equipment lifecycle for an aseptic filling (vials) and integrated Isolator system (VHP); URS owner, vendor engagement, detailed design support and vendor construction PM.


If you are interested, please do not hesitate to email or call me!