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Packaging CQV

  1. Denmark
Denmark
  1. Contract
Competitive
  1. Commissioning, Qualification and Validation
36927
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Packaging CQV - Denmark - 6-12 Months Contract 

Our client, a global CDMO in pharmaceutical manufacturing, is recruiting for a Packaging CQV 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 bio pharmaceutical industry.

 Responsibilities include:
  •  Be a hands-on technical expert in commissioning, and qualifying our packaging line for pen-devices, prefilled syringes, and other products.
  • Work closely with colleges and equipment vendors ensuring that the chosen solutions are documented, tested and implemented.
  • Review/approve test plans, write pFMEA, IQOQ testing and reporting.
  • Produce a complete list of validation documents need to validate the facility and technical installations.
  • Review test plans and test reports from vendors.
  • Liaise with all Project Groups (Design/CM/CQV/Automation/Process/SMEs/Ops/Maintenance/PMs) to ensure documents are created are managed appropriately for the Project Lifecycle.
  • Liaise with CQV Document Generation Lead / Project Director in relation to generation and approval of documents.
  • Generate and assist in the timely approval of all Commissioning and IOQ Final Reports.
Key requirements include:
  • Extensive technical background and experience with Finished goods packaging.
  • Experience with qualification and implementation of Packaging machines.
  • Experienced in writing test plans and understand liaising with quality assurance.
  • Years of experience in qualification of equipment
  • Pharma experience is a requirement.
  • Solid technical background and experience.
  • Ability to keep work pace and meet deadlines.
  • Demonstrated proficiency communicating and collaborating at a variety of levels.
  • Strong communication skills. Problem solver with a focus on achievement of overall project goals.
  • Computer skills (Compliance wire & EIDA)
If this role is of interest, please apply now!
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