QA Validation Specialist

Posted on: 17/11/2020
Ref: VAC-18648
 
  • Country: Ireland
  • Location: Dublin
  • Industry: Quality Assurance
  • Discipline: QA Validation
  • Employment Type: Contract
  • Duration: 52 weeks+

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Job Description

LSC have a great contract opportunity for a QA Validation Specialist to join a biopharmaceutical company based in Dublin. The company is focused on serving patients with severe and ultra-rare disorders through the innovation, development and commercialization of life-transforming therapeutic products.

If you have min 5 years QA experience in a pharmaceutical manufacture/biopharmaceutical environment. (BDS experience is essential) and are ready for your next challenge, this could be the perfect project for you!

ABOUT THE PROJECT – KEY RESPONSIBILITIES:
o Provide quality and cGMP input and oversight for all start-up project activities through commercial readiness and ongoing product disposition.
o Provide QA support for risk based verification activities in the capacity of Quality Assurance Subject Matter Expert. Review and approval equipment/utilities verification documentation from design to post execution.
o Participate in verification quality risk assessments and provide quality oversight to ensure verification quality risk assessments are effectively maintained/controlled.
o QA support for implementation of Manufacturing Execution System (MES) computer system validation deliverables.
o Review and approval of engineering functional area documentation (SOP, Work Instructions, Criticality Assessments, technical report and protocols).

ABOUT YOU – ARE YOUR SKILLS A MATCH?
o B.Sc. in science/pharmacy with a minimum of 5 years’ experience in cGMP Quality environment to include biopharmaceutical experience.
o Must have strong process knowledge to include upstream and/or downstream processing.

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!

To apply, submit your CV via this advert or contact Conor Dolan at LSC on 021-4777329 if you have anymore questions about this QA Validation Specialist opportunity!

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