QA Specialist

LSC have a great contract opportunity for a QA Specialist to join a global Biopharmaceutical company in Carlow. This is a state-of-the-art vaccines and biologics manufacturing facility currently producing many products in various therapeutic areas including: oncology, autoimmunity, pneumonia, and infectious disease. If you have 3 years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you ABOUT THE PROJECT - KEY RESPONSIBILITIES: Provide quality oversight and direction for the introduction of new products. Serve as the point of contact for quality at both the site level and with external inputs, coordinating and attending Quality working group meetings. Conduct quality reviews and approvals of engineering/validation/automation/utilities commissioning and qualification activities. Author, review, and approve protocols and reports for technology transfer, method qualification, and method validation. Review documentation associated with new product, such as, QC Test Specifications, BOMs, and MES documentation. Support deviation close out in a timely manner. Facilitate compliance direction for the site by adhering to divisional policies, guidelines, and regulatory requirements. ABOUT YOU - ARE YOUR SKILLS A MATCH? A Bachelor's degree or higher in a related Science discipline is preferred. A minimum of 3-5 years of experience in a quality role, ideally in a pharmaceutical manufacturing environment. Knowledge of regulatory/code requirements related to Irish, European, and International Codes, Standards, and Practices. Experience with equipment and process validation. Familiarity with sterile filling processes and equipment. Proficiency in Microsoft Office and job-related computer applications. Experience or familiarity with Lean Six Sigma methodology is desired. Proven ability to drive the completion of tasks. Strong decision-making capability with a sense of accountability and responsibility. Demonstrated problem-solving skills. Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply Apply via this advert or contact Grinne Hodnett at LSC on if you have any more questions about this role Skills: Quality Assurance GMP QA Validation Equipment Validation Process Validation NPI New Product Introductions