Are you currently working as a Quality professional in either the Pharma, Med-Device, or 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 the 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.
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