Quality Assurance Role Hillerød, Hillerød Municipality

QA Engineering

  • Posted Nov 24, 2022
  • Hillerød, Hillerød Municipality
  • Contract
  • BBBH25986

LSC has a fantastic contract opportunity for QA Engineer to join the QA Engineering group ii advanced global team in Denmark on that promotes self-development, encourages collaboration, and fosters a learning environment. The company specializes in clinical & commercial manufacturing of Biotech medicines, including viral gene therapies and has built a strong reputation over the years for bringing complex and lifechanging therapies into reality. This is a chance for you to be a part of a fast-growing, multicultural company that has a compelling vision for shaping the future of medicine.

ABOUT THE PROJECT - KEY RESPONSIBILITIES:

Working with QA Engineering as a QE lead on major processes and support equipment such as Automatic Inspection line, Formulation equipment, Sterile Filtration skids, Part Washer and Autoclave. You will have input into, review and approval of documents related to IT & Automation systems such as Pas-X (EBR/MES), VDS and Delta V is also expected. Responsibilities include:
  • Actions related to FAT prerequisites e.g. ensure that Change Management Records (CMR) are in execute, perform GDP training of Vendor's testing personnel etc.
  • Review and approval validation documentation (protocols, design specifications RTM etc.)
  • Participate in Quality Risk Management processes - Review of test documentation (FAT/SAT/IQ/ OQ/PQ) including deviations found during testing -
  • Supervision of vendors/contractors during relevant validation activities to ensure correct level of quality -
  • Turnover package reviews, both from vendor and contractor.

ABOUT YOU - ARE YOUR SKILLS A MATCH?

  • Minimum 5 years proven experience and knowledge within the following areas:
  • QA approval of qualification documents and SOPs
  • Experience with projects and working in or around operating facilities
  • Working knowledge of principles, concepts and practices of ASTM E2500 / Leveraging Verification process, CFR 21 Part 11 and EU GMP Annex 11 Knowledge of regulatory requirements for aseptic processes and validation (EU GMP Annex 1 and Annex 15)
  • CAPA, Deviation and Change Control handling
  • QA approvals in Computerized Maintenance Management System *

Apply via this advert or contact Sarah Ninan at +353 214771329 if you have any more questions about this opportunity!



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The benefits of contracting with LSC

  • Partners to the world’s top Life Science companies we offer you the best contract opportunities in the industry
  • 95% of LSC contracts are renewed letting you choose contracting as a long term career option
  • LSC’s Consultant Success Programme focuses on skills development & on-site support to help you achieve your career goals!

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