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QA Validation Specialist

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Job Summary

  • Cork
  • Contract
  • JN -012024-1954624
  • Jan 23, 2024
  • €30 - €40 ph
Job Description

We have amazing opportunity for a QA Validation Specialist to work for a Global Pharmaceutical company based in Cork on an initial 12 month hourly rate contract.

DESCRIPTION

In this role, you will be providing quality oversight on C&Q projects. You will need have a minimum of 2 - 3 years' experience working in C&Q activities ideally in the area of equipment or utility qualification.

In this position you will be responsible for the execution, review and approval of validation activities in a GMP regulated environment making sure the new manufacturing processes, equipment, lab systems and computer systems are being implemented along with any changes to existing equipment.

A high level of initiative, energy and motivation are key role requirements, as well as organisational skills.

RESPONSIBILITIES

  • Provide oversight for FUE activities related to the companies' products and FUE.
  • Develop validation plans for specific implementation projects.
  • Perform and review lifecycle documentation (URS, Commissioning, Qualification Protocols) validation activities related to the implementation of FUE changes.
  • Establish Site Validation Policies, through development, generation and implementation of validation master plans, documents and SOP's.
  • Maintain knowledge of industry standards and regulatory requirements for products developed or manufactured by the company.
  • Lead the Validation team in multi-departmental meetings & project teams.
  • Identify and implement improvements to the QA Validation systems.
  • Take part in the change control program for modifications to qualified systems.
  • Coordinate validation activities involving cross-functional, multi-departmental teams including: Engineering, Manufacturing, Process Sciences, Quality Control, Quality Assurance, Regulatory Affairs, and others.

EDUCATION

  • Bachelor of Sciences degree, or higher, in a technical discipline is required.

EXPERIENCE

  • +4 years' experience in a cGMP regulated manufacturing environment, with knowledge of equipment and utility validation, and laboratory systems / validation.
  • Ability to speak, present data, and defend approaches in front of audiences and inspectors.
  • Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
  • Experience with participation in regulatory inspections presenting or defending departmental functions in audits or regulatory inspections.
  • Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for equipment validation expectations.
  • Proficiency with technical summary report generation required, with exceptional organisational, spelling, grammar, and typing skills preferred.

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

James Kind
James Kind