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 021 4777329 if you have any more questions about this role!
