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Contact Info
Ruth Holland
Life Science

01 507 9255
[email protected]
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Details

QA Validation Associate


Reference:/RH/APPG-007585 Location: Cork
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed

Life Science Recruitment are recruiting for QA Validation Associate to join the team with ourIT/Validation Consultancy. This role will be based on site with a Pharmaceutical client in Cork.


This position is responsible for the execution, review and approval of validation activities in a GMP regulated environment, focused on implementation of new manufacturing processes, equipment, computer systems, laboratory systems and changes to existing equipment.


Role/Responsibilities:

  • Provide project management oversight for FUE activities related to company's products and facilities, utilities, equipment (FUE).
  • Developing validation plans for specific system implementation projects.
  • Performing and reviewing (project lifecycle documentation (URS, RA, Commissioning, Qualification Protocols)) validation activities related to the implementation of facilities, utilities, equipmentchanges while exercising judgment within broadly defined procedures and practices to establish approval criteria, and identify and implement solutions.
  • Establish Site Validation Policies, through development, generation and implementation of validation master plans, guideline documents and SOP’s.
  • Lead and represent Validation in multi-departmental meetings & project teams.
  • Identifies and implements improvements to the QA Validation systems.
  • Participation 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 and Experience:



  • Bachelor of Sciences degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required.
  • 5+ years’ experience in a cGMP regulated manufacturing environment, with knowledge of equipment and utility validation, and laboratory systems / validation.
  • Organizational and management skills to coordinate multi-discipline project groups
  • 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 organizational, spelling, grammar, and typing skills preferred.

For more information contact Ruth Hollandon 087 7822 198 or [email protected]