Job Description
A Quality Professional in Pharma, Med-Device, or Biotechnology looking for a new challenge? We have an exciting opportunity for a QA Validation Associate to join our team on a 12-month contract based in Cork.
You will be responsible for executing, reviewing, and approving validation activities in a GMP regulated environment, focusing on implementing new manufacturing processes, equipment, computer systems, laboratory systems, and changes to existing equipment.
Key Responsibilities:
* Maintain project management control for FUE activities involving equipment, utilities, and facilities.
* Develop validation plans for specific system implementation projects.
* Perform and review 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.
* Lead multi-departmental meetings and project teams, representing Validation.
* Identify and implement improvements to the QA Validation systems.
* Coordinate activities involving cross-functional teams: Engineering, Manufacturing, Quality Control, Quality Assurance, and Regulatory Affairs.
Requirements:
* 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.
* Understanding of FDA & European regulatory requirements, guidelines, and recommendations for equipment validation expectations.