LSC have a great contract opportunity for a Quality Assurance Specialist to join a top 10 Pharmaceutical company based in Tipperary.
In this new role the Ideal Candidate will work with / as part of Global Development Quality team with responsibility for GMP Quality Assurance activities for the IMP License
ABOUT THE PROJECT - KEY RESPONSIBILTIES:
- Complete auditing/ review of batch documentation to ensure compliance to SOPs, GMPs and applicable regulations
- 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
- Manage product recalls and stock recoveries as appropriate
- Identify compliance gaps and make recommendations for continuous improvement
- Create and maintain assigned SOPs
- Perform and review complaints and deviation investigations, change controls and CAPA's.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- The Specialist is required to possess a degree in a Quality, Science or Engineering discipline and potentially a higher degree and/or significant industrial experience. They must possess > 3years industrial experience
- Experience should be in the pharmaceutical/chemical industry or government drug-regulatory agency with a working knowledge of cGMP regulations. Effective communications (oral/written) and interpersonal skills are necessary
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!
Call Pawel Jurkiewicz at LSC on 021 4777 329 for more information on this new Quality Assurance Specialist position or apply directly via this advert.