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QA Specialist

  1. Cork
  1. Contract
Competitive
25998 AB
  1. Compliance / Quality Assurance
Date Posted04 Jan 2021
QA Specialist – CMO – Contract – 12 months – Cork, Ireland

I am currently working with a Leading Global Pharmaceutical client, based in beautiful Cork, Ireland.

The client is looking for an experienced QA Specialist to support their Global Quality function.

The QA Specialist will communicate with various manufacturing facilities based globally, and act as point of contact in Ireland.

The QA Specialist will provide quality leadership, direction and governance for products manufactured at contract manufacturer and therefore CMO experience is a must.

Responsibilities / Experience:
  • Responsible for ensuring the governance of contract manufacturer is carried out in compliance with site procedures. 
  • Support the development and maintenance of the contract manufacturing governance program (quality systems, procedures, quality agreements etc)
  • Liaises and manages quality-related matters with contract manufacturer and site QA.
  • Review and/or approve GMP documents associated with qualification including IQ/OQ/PQ for facility, equipment, computer systems, GMP utilities, and validation documents including analytical methods, process and cleaning validation.
  • Contributes to the audit scope/plan of the contract manufacturer.
  • Monitors and tracks the contract manufactures’ GMP compliance to Quality Agreement requirements and conformance to Quality Plan items e.g. audit observations/CAPA implementation etc.
  • Carry out day-to-day activities in compliance with site safety policies and procedures.  Promote and encourage safe practices & promptly report any safety concerns.
 

Requirements:
  • BSc, MSc, or PhD in Biotech, Chemistry, Microbiology, Engineering or related scientific discipline, with a minimum of 5-7 years of relevant experience.


The candidate must have the rights to work in the location stated in the job advert.

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