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Quality Validation Specialist

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Job Summary

  • Cork
  • Permanent
  • JN -012024-1954276
  • Jan 18, 2024
  • Competitive
Job Description

This is a new role within a highly successful and respected business that provides cutting edge technologies and solutions to the pharma and biotech industries.

With continued growth expected this company are seeking an experienced Quality specialist with a solid background in Validation support to join their expanding team.

Overview of Role

  • Reporting to the Compliance Lead this position requires an effective collaborator to work cross-functionally, and as part of a team. With a strong focus on supplier and customer management this role will facilitate continuing compliance of the QMS.
  • This role is key to maintaining the quality and safety of products for the bio/pharmaceutical market, ensuring the company meets the specification requirements of its multinational customers, and assuring the security of the supply chain and the company's interests.

Key Responsibilities

  • Review and update of SOPs and quality critical documentation
  • Review and approval of Engineering Drawings
  • Creation of validation protocols and monitoring of process validation activities.
  • Performing material qualification and provision of customer specific validation requirements
  • Drafting and timely execution of actions for Change Control and CAPA
  • Update of key tracking tools for QMS
  • IQ OQ PQ Validation support, protocol and report writing.
  • Liaising with customers and deliverance of expected requirements within agreed timelines.
  • Operational excellence initiatives
  • Quality risk & opportunity activities
  • General documentation control.
  • Other responsibilities as required.

Experience & Qualifications

  • 3-5 Years + in a Quality / Validation function in a GMP/regulated environment
  • Bio/Pharmaceutical, Medical Device, Nutraceutical or Food Science background
  • Graduate with scientific degree or qualifications in science, engineering, technology
  • Exposure to customer/regulatory audits
  • Material qualification and validation experience
  • Strong documentation writing skills
  • Ability to work independently and on your own initiative but also able to build strong relationships with clients and co-workers

If you would like to find out more about this role please click the 'Apply Now' button below or reach out to Kellie on 021 2300 300.

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

Kellie O'Donovan
Kellie O'Donovan