Qa Cqv Sr Specialist

2 weeks ago

Dundalk, Ireland Life Science Consultants (Lsc) Full time

LSC have a great contract opportunity for Quality Assurance CQV to join a leading Biopharmaceutical Facility in Louth.If you have 5 years of experience and are ready for your next challenge, this could be the perfect project for youABOUT THE PROJECT - KEY RESPONSIBILITIES: Ensure the quality oversight of the qualification/validation activities of all facilities, utilities, equipment, computerized systems, cleaning processes, manufacturing processes, storage areas, controlled temperature units (CTUs) and shipping processes.Ensure that all validation documentation and associated data, including but not limited to; plans, URSs, quality risk assessments, protocols, and reports, are reviewed and approved by QA for conformance to SOPs, specifications and other applicable acceptance criteria.Ensure that all events/deviations, investigations, and change evaluations that occur during qualification/validation activities have appropriate QA oversight, QA review and approval and adhere to SOPs and cGMP requirements.Review SOPs relating to qualification/validation activities.Provision of support in Regulatory inspections and Client audits.Provision of QA Validations expertise to maintain validation status of the facility.ABOUT YOU - ARE YOUR SKILLS A MATCH?B.Sc or B.Eng in a Scientific or Engineering related discipline (e.g. biochemistry, chemistry, engineering).Experience in a Quality Engineering/Quality Assurance/Quality Validations role for Biologics or related pharmaceutical/ medical device manufacturing in a FDA/ EU regulated environment.For our contracting positions in Ireland's pharmaceutical industry, applicants must possess a Stamp 1G or a Stamp 4 visa.We apologize for any inconvenience, as visa sponsorship is not available currently.Apply via this advert or contact Kathy Gillen on if you have any more questions about this opportunity

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