Senior QA Specialist-PTQA

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 : Act as Quality point of contact and decision maker during New Product Introductions, Technology Transfer and Process Validation activities for Aseptic products Quality review and approval of Process Development and Validation documentation Technical transfer documents Validation Protocols, executed validation documents and reports Provide Quality direction and input at Change Control and Deviation Review Boards and assume QA oversight of change control and Deviation / CAPA records ABOUT YOU - ARE YOUR SKILLS A MATCH? University degree. Science or Engineering related discipline preferred. Understanding of principles of Validation and New Product Introduction Experience in aseptic manufacturing Relevant experience (7yrs +) working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing overall quality direction and oversight for key functional areas (i.e. Process Development, Validation, Manufacturing) Experience in change control, non-conformance, corrective and preventative actions, and validation practices. Ability to work independently and remotely with minimum direct supervision. Critical thinking skills. 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 Quality oversight NPI Tech transfer