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QA Specialist

Job Seekers Ireland Science Life Science

Job Summary

  • Cork
  • Contract
  • BBBH802999
  • Jan 06, 2022
  • €30 - €40 ph
Job Description

Are you a Quality Assurance Specialist based in Cork wanting to join a renound Pharmaceutical company? This is an excellent opportunity to join a leader in their field on a 12 months contract basis.

Job Description

Are you a Quality Assurance Specialist based in Cork wanting to join a renound Pharmaceutical company? This is an excellent opportunity to join a leader in their field on a 12 months contract basis.

QA Specialist - Pharmaceutical - Cork

An exciting opportunity for a QA Specialist to join an expanding team in Cork. The QA Specialist will be responsible for managing compliance activities and QA operational activities related to operational projects as required by Good Manufacturing Practice (GMP). The ideal candidate will have previous experience working in API Plant.

Key Responsibilities:

  • Review and approval of GMP documents associated with qualification and validation including but not limited to change controls, IQ/OQ/PQ & validation documents for facility, equipment, computer systems, GMP utilities, analytical methods, and processes, stability data and periodic review reports (PRR) and annual product reviews (APR)product quality evaluations.
  • Oversee the planning, implementation, and follow-up for internal and external inspections.
  • Ensure that internal and external Quality Issues and CAPAs are properly prepared, executed, and followed up on.
  • Review and approval of change controls, deviations, investigations, suspect analytical results, product quality complaints, stability studies and reports associated with the manufactured batches.
  • Approval of batch records for API.

Key Requirements:

  • BSc, MSc, or PhD in Biotech, Chemistry, Engineering or related discipline, with a minimum of 3 years relevant experience.
  • Extensive knowledge of cGMP/GDP regulations up-to-date knowledge of Irish and EU legislation and guidelines.
  • Manufacturing / QA operations knowledge is required where the position demands oversight of manufacturing / packaging / testing operations activities (internal or external).
  • ISO requirements are well-understood and well-practiced.

If you believe this would be a good fit for you, or would like to find out more about this role, click the 'apply now' button or reach out to our Specialist Consultant Aisling Couch on 021 2300 300 or acouch@morganmckinley.com today.

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.

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Consultant Details

Consultant Details

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Aisling Couch
  • Recruitment Coordinator | Engineering & Science Recruitment
  • +353 21 2300 300
  • acouch@morganmckinley.com