QA Operations Specialist (Shift)

LSC have a great contract opportunity for QA Operations Specialist to join a leading biotech company based in Dublin. If you have 3 years of experience and are ready for your next challenge, this could be the perfect project for you! ABOUT THE PROJECT - KEY RESPONSIBILITIES : Provide direct Quality support to production and support areas. Provides presence on the shop floor to support compliance and data integrity. Review and approve GMP documentation / data for accuracy and completeness. Review and approve executed production documentation such as electronic batch records and logbooks to ensure accuracy and compliance with cGMPs and company procedures and ensures completion of proper remediation of errors. QA support, review and approval of C&Q, Performance qualification (PQ) & Process Validation documents. Support sustaining activities such as change management, deviations, CAPAs, equipment requalification, periodic review, site maintenance & Calibration Programs ABOUT YOU - ARE YOUR SKILLS A MATCH? Bachelor degree, in a scientific or engineering field. 3 years of relevant post-degree experience in a GMP environment : manufacturing, laboratory, quality, operations, technical, or regulatory function. Knowledge of cGMPs and of regulatory requirements as they apply to the pharmaceutical field. Technical writing skills. Lean Six-sigma and problem-solving tools 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 Grainne Hodnett on if you have any more questions about this opportunity! Skills : GMP Data Investigations Downstream