Job Description
You are a quality professional looking to make a change in your career? We are seeking a QA Validation Associate to work with us on a 12-month hourly rate contract.
You will be responsible for executing, reviewing, and approving validation activities in a GMP regulated environment. Your focus will be 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 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.
* Lead cross-functional, multi-departmental teams including: Engineering, Manufacturing, Quality Control, Quality Assurance, and Regulatory Affairs.
* Identify and implement improvements to the QA Validation systems.
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.
We are a leading biotechnology company based in Cork. Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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