Validation Quality Assurance Manager

3 days ago


Cork, Cork, Ireland Pm Group Full time

Job Description

Pm Group is seeking a skilled and experienced QA Validation Specialist to join a Client Validation team.

The successful candidate will be responsible for reviewing and approving validation lifecycle activities in a GMP regulated environment, focused on implementation of new manufacturing processes, equipment, computer systems, laboratory systems and changes to existing equipment.

The role involves providing project management oversight from a Quality perspective for FUE activities related to products and facilities, utilities, equipment (FUE).

Key Responsibilities:

  • Review and approval of project lifecycle documentation (URS, RA, Commissioning, Qualification Protocols)
  • Establish Site Validation Policies through development, generation and implementation of validation master plans, guideline documents and SOP's
  • Maintenance of current knowledge of industry standards and regulatory requirements for products developed or manufactured by the client

Qualifications

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



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