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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