QA Snr Associate Shift

4 weeks ago

Dublin, Dublin City, Ireland Life Science Consultants (LSC) Full time

LSC have a great opportunity for QA Associate (Shift) to join a South Dublin-based Biopharmaceutical company that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging. If you have 4+ 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: Review and approve production batch records and associated documentation for Qualified Person disposition activities. Provide real-time quality oversight and support for production unit operations, extending to formulation, vial and syringe Fill Finish activities Offer Quality Assurance support for on-the-floor investigations and deviations. Review and approve deviations for closure, ensuring compliance with appropriate documentation. Participate in customer complaint investigations. Conduct routine Quality Assurance walks on the production floor. ABOUT YOU - ARE YOUR SKILLS A MATCH? University degree. Engineering or Science related discipline preferred. Relevant experience (4 yrs. +) Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products. Exceptional written and verbal communication skills. Proven experience collaborating with dynamic cross-functional teams and strong decision-making abilities. Demonstrated problem-solving abilities, particularly in supporting non-conformance/deviation investigations. Experience in inspecting vials and syringes and engaging in aseptic operations. Familiarity with applicable Regulatory requirements and proficiency in evaluating compliance issues. Applicants interested in our contracting opportunities within the pharmaceutical sector in Ireland are required to have a Stamp 1G 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 Grinne Hodnett on if you have any more questions about this opportunity Skills: GMP inspections deviations Regulatory requirements

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