LSC have a great contract opportunity for a QA Specialist to join a top 10 Pharmaceutical company based in Tipperary. The site supports the complete pharmaceutical small molecule process for Phase III clinical to product release and market support. On site processes include API manufacture, formulation, OSD tableting, packaging and global logistics & distribution. The facility takes in raw chemicals and ships finished medicines to end users. This site has grown from an API site to a strategically important campus that supports critical stages of the company's drug lifecycle.
If you have a degree in a Science or Engineering discipline plus some industrial experience and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Review and approve production and analytical documentation accompanying the release of drug substance, drug product and packaged finished goods to ensure conformance to appropriate SOPs, GMP and regulatory requirements, including supporting QP certification.
- Perform and review complaints and deviation investigations, change controls and CAPA's.
- Creates and maintains assigned SOPs.
- Completes audits to ensure compliance to SOPs, GMPs and applicable regulations.
- Support product recalls and stock recoveries as appropriate.
- Actively communicate and collaborate with functional areas to develop a strong working relationship and understanding of roles and responsibilities. Utilize this network to help resolve comments and issues that arise during audit and review.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Carries out all assignments to the standards of compliance, efficiency, innovation, accuracy, and safety in accordance with Company and regulatory requirements.
- Keeps abreast of cGMP requirements as described in applicable worldwide regulations.
- Identify compliance gaps and make recommendations for continuous improvement
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 Grainne Hodnett at +35321 477 7329 if you have any more questions about this QA Specialist opportunity!