Quality Assurance Specialist Senior – Technical QA

4 weeks ago

Dublin, Ireland Life Science Consultants (LSC) Full time

LSC have a great opportunity for a Senior QA Specialist to join a South Dublin-based Biopharmaceutical company that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging. If you have 7+ years of experience in construction management/engineering within the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect project for you ABOUT THE PROJECT Key Responsibilities: Provide QA leadership during facility design, and layout Provide overall quality direction for processes and procedures associated with project Lead QA review and approval of URS, DS, QRAEs, and IQ/OQ/PQ protocols and reports. Act as the Quality point of contact and decision-maker during validation execution activities, ensuring all activities comply with regulatory and company standards. Ensure Computerised System Validation (CSV) meets regulatory and data integrity standards. Ensure validation documentation is robust, traceable, and inspection-ready. Drive risk assessments and mitigation strategies for new equipment and processes. Provide QA oversight for Change Controls, CAPAs, and Deviation Investigations. Ensure all activities align with Amgen's safety standards, SOPs, and regulatory expectations. Support a safe working environment by adhering to all environmental health and safety practices, rules, and regulations. Preferred Qualifications: * University degree in a Science or Engineering-related discipline. * Minimum of 10 years of relevant experience in the pharmaceutical or biotechnology industry. * Proven expertise in facility startup and Quality Oversight of Validation activities. ABOUT YOU - ARE YOUR SKILLS A MATCH? Applicants interested in our contracting opportunities within the pharmaceutical sector in Ireland are required to have a Stamp 1G visa or a Stamp 4 visa. Please note that we are unable to provide visa sponsorship. Thank you for your understanding. Apply via this advert or contact Siobhan Cummins on if you have any more questions about this opportunity

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