My client is a world leading technology company who's looking for a QA Validation Associate on permanent basis.
- Providing project management oversight for FUE activities related to company's products and facilities, utilities, equipment (FUE).
- Develope validation plans for specific system implementation projects.
- Perform and review (project lifecycle documentation (URS, RA, Commissioning, Qualification Protocols)) validation activities related to the implementation of facilities, utilities, equipment changes while exercising judgment within broadly defined procedures and practices to establish approval criteria, and identify and implement solutions.
- Establishing Site Validation Policies, through development, generation and implementation of validation master plans, guideline documents and SOP’s.
- Leading and representing Validation in multi-departmental meetings & project teams.
- Identifing and implementing improvements to the QA Validation systems.
- Participating in the change control program for modifications to qualified systems.
- Coordinating validation activities involving cross-functional, multi-departmental teams including: Engineering, Manufacturing, Process Sciences, Quality Control, Quality Assurance, Regulatory Affairs, and others.
- 5+ years’ experience in a cGMP regulated manufacturing environment, with knowledge of equipment and utility validation, and laboratory systems / validation.
- 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.
- Bachelor of Sciences degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required.
For a confidential discussion on this or any other current job opportunity please contact Marcel Skolimowski on 021 4847 138 / marcel at sigmar.ie
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