LSC have a great contract opportunity for an 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.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Perform and review complaints and deviation investigations, change controls and CAPA's.
- Creates and maintains assigned SOPs.
- Compiles data for reports and presentations, provides data interpretation draws conclusions.
- 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. Utilise this network to help resolve comments and issues that arise during audit and review.
- Generally, follows standard procedures and consults with manager/supervisor on exceptions.
- 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.
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!
Contact Grainne Hodnett in LSC on 021 4777 329 to discuss this new role in detail or apply directly via this advert