QA Associate (Shift)

IrishJobs

Cork, Cork, Ireland

Cork, Cork, Ireland

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LSC have a great contract opportunity for a QA Associate (Shift) to join a Cork based Biopharmaceutical company. The site manufactures low volume bulk API for Phase III clinical trials, initial product launch and long-term market support. The team on site grow, purify, formulate, and bulk fill mammalian cell culture derived APIs for medicines intended for human use. If you have 5 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 direction and oversight of the start-up, technical transfer, operation, and continuous improvement of Sterile Drug Product Filling operations. Provide Quality input to Change Controls, Protocols and Reports ensuring scope of records are clear and implementation activities are robust and timely. Write, review and approve Standard Operating Procedures, Work Instructions, Quality Technical Agreements, Master Batch Records, Specifications and other GMP documentation Participates within inter-departmental and cross-functional project teams to immediately address issues and questions in real time to help ensure project timelines are achieved. Prioritizes tasks to ensure the critical tasks are completed on time and meet requirements. Provide Quality input and guidance to ensure Lot Release (Components/Raw Materials/Drug ABOUT YOU - ARE YOUR SKILLS A MATCH? Degree or 3rd level qualification (Science, Quality). QP Qualification would be an advantage. Demonstrated experience in Sterile Drug Product Filling and start-up of same. Relevant experience (5yrs +) working in a Quality function in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the other requirements of the role. 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 Cian Marnane at LSC on if you have any more questions about this role! Skills: Drug Product Manufacturing Quality Assurance Validation

TLNT1_IJ

Cork, Cork, Ireland

Sprachkenntnisse

English

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