LSC have a great contract opportunity for a Quality Assurance 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 knowledge and demonstrated expertise in Lean / Continuous Improvement, Reviewing and approving batch, cleaning and testing documentation, and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Participate as functional expert in the cross functional team that manages production right first time.
- Review and approve batch, cleaning and testing documentation.
- Ensure that all Laboratory Out of Specification (OOS) and Process Deviations are documented, assessed and associated CAPA identified.
- Provide detailed knowledge of quality systems in place and ensure that root cause is identified and corrective actions as appropriate are completed.
- Provide guidance on quality requirements to maintain validation status, including participation in Process / Product Risk Assessments.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Degree or post-graduate qualification in Science, Pharmacy or equivalent.
- Experience and knowledge of GMP Requirements for Electronic / Paper free operations.
- Knowledge of Quality IT systems desirable (e.g. SAP, Trackwise).
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!
To apply, submit your CV via this advert or contact Pawel Jurkiewicz at LSC on +353 21 2067 446 if you are interested in this Quality Control Specialist opportunity!