QA Validation Associate

Job Description

Are you currently working as a Quality professional in either the Pharma, Med-Device, Biotechnology industry and looking to make a change to your career?

Look no further, as I am currently seeking a QA Validation Associate to work for a leading biotechnology company based in Cork on a 12 month hourly rate contract.

You will be 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.

Requirements:

• Maintain project management control for FUE activities involving equipment, utilities, and facilities.
• Develop validation plans for specific system implementation projects.
• Perform and review the project lifecycle documentation (URS, RA, Commissioning, Qualification Protocols)
• Develop, produce, and implement validation master plans, guidelines, and SOPs to establish site validation policies.
• Maintain current knowledge of industry standards and regulatory requirements for products developed.
• In multi-departmental meetings and project teams, take the lead and represent Validation.
• Identify and implement improvements to the QA Validation systems.
• Coordinate activities involving cross-functional, multi-departmental teams including: Engineering, Manufacturing, Quality Control, Quality Assurance, and Regulatory Affairs.

Required Experience & Qualifications:

• Bachelor of Science / Engineering Degree in a relevant field
• 3 years experience in a cGMP regulated manufacturing environment, with knowledge of equipment and utility validation, and laboratory systems in a Biotechnology environment.
• Understand FDA & European regulatory requirements, guidelines, and recommendations for equipment validation expectations.

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.