Quality Control Specialist

Location
Meath, Dunboyne
Salary
Negotiable
Posted
30 Sep 2021
Closes
28 Oct 2021
Ref
BBBH3957
Contact
Martin Taggart
Sector
Scientific
Job Type
Contract
Hours
Full-time

Manpower have an excellent opportunity for a Quality Control Specialist with 4 to 6 years of experience. This role will be based with our Biopharmaceutical client based in Meath.
Responsibilities include:

  • Supporting the qualification and validation activities and agreeing best practices in line with applicable GMP Regulations.
  • Quality SME for the execution and reporting phases of the qualification and validation activities associated with the BioNX facility.
  • Review and Approve all documentation where required specific to Qualification / Validation activities.
  • Ensure any investigations / deviations associated with the validation activities are thoroughly investigated and closed in a timely manner
  • Oversee the Project Change Management Process and approve Project Change Requests where required.



Experience required:

  • Significant experience in a QA/Validation related position within the pharmaceutical or life-sciences industry.
  • Strong experience with Validation in project related activities i.e. Experience of the Validation lifecycle particularly the qualification of process equipment, utilities and HVAC associated within a Drug Substance facility.
  • Strong experience in Validation to ensure compliance to Annex 15, EU regulations, applicable US FDA Guidelines and ASTM E2500
  • Strong experience of Computer System Validation regulations in line with 21 CFR Part 11, Annex 11 and Annex 15.
  • Knowledge and understanding of EU and US cGMP regulations with respect to the validation, production and testing of pharmaceutical and/or biological products.
  • Track record of utilizing Risk Based Approaches to Qualification / Validation activities.
  • Strong track record of identifying, escalating and correcting compliance issues and implementing process improvements.

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