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QA Validation Specialist, Westmeath



Westmeath, Ireland 

Job Category:

Biotech/Pharma, Science

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Job Description:

We are seeking applications for an experienced QA Validation Specialist for our client, who is a leading biopharmaceutical company based in Dublin.
Why you should apply:
  • This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
  • There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
  • Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.
What you will be doing:
  • The QA Validation Specialist performs review and approval activities to support validation activities in the Company’s cGMP commercial and clinical requirements for the Company Manufacturing Facility. The responsibilities of the incumbent will include performing review and approval of validation documents such as policies, master plans, procedures, specifications, investigations, protocols and reports, as well as and support of validation documentation control and archival
What you need to apply:
  • Minimum of degree qualification in relevant science and/or engineering discipline
  • 5 Years minimum post educational experience with working in a regulated environment preferably within a Pharma/Biotech facility.
  • 3 years in a Validation function with strong knowledge of CSV/GAMP, 21 CFR Part 11, Project Life Cycle and cGMP Regulations. Experience of ASTM E2500 would be a distinct advantage.
  • Direct experience performing review and approval of validation studies in cGMP biopharmaceutical or aseptic liquid filling and QC environments is required.
  • Excellent interpersonal skills are required, as is the ability to communicate well, both verbally and written.  Must be able to function effectively in a teamwork environment.
  • The incumbent should possess knowledge of cGMP requirements for biopharmaceutical and/or aseptic liquid filling processes and QC testing processes.
  • The individual in this position is expected to represent the Company’s interests, objectives and policies in a professional and responsible manner.
  • Two - five years’ experience in a cGMP environment is preferred
  • Management experience is an advantage
Company Info
Team Horizon
1 Cedar Crescent, Cedar Park, Westport, Co. Mayo
Westport, Ireland
Phone: +353 98 50600
Web Site: http://www.teamhorizon.ie
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