C&Q Engineer Role Denmark

Project Quality Assurance Specialist and Lead

  • Posted Dec 15, 2023
  • Denmark
  • Contract
  • BBBH27167

LSC has a fantastic opportunity for a QA specialist to join our Drug Product (DP) manufacturing project (fill finish). The person will manage Project Quality Assurance (PQA) activities in the PQA Lead role to support the implementation of a new DP facility. Beside the PQA lead role he/she will also be the responsible QA on one of the major process equipment packages, preferable the isolator-based filling line. Key responsibilities:
  • Lead up the DP Project QA (PQA) through SAT, IQ, OQ and PQ activities.
  • Be very visible in the project and DP organization and therefore have strong stakeholder management skills.
  • Create, approve and maintain quality plans and procedures.
  • Review and approve SAT/IQ/OQ and PQ for major process equipment e.g. filling line (preferable) or automatic inspection machine.
  • Continuous align with CQV Project Lead on CQV process to be utilized on the project with consideration given to ASTM E2500 and leveraging from FAT into IOQ.
  • Review and approve updates to Validation Project Plans covering Process-and support equipment IT/Automation, clean utilities and facility.
  • Oversight over project change management planning and execution.
Education and experience:
  • You have +10 years of QA for engineering/validation experience including experience with design and construction projects, preferable with fill-finish equipment and facility.
  • Strong leadership skills with knowledge on how to set the direction for the project regarding quality.
  • Working knowledge of principles, concepts, and practices of ASTM E2500 / Leveraging Verification process.
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply! Apply via this advert or contact Sarah Ninan at +353 214777329 if you have any more questions about this opportunity!

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