LSC have a great contract opportunity for a Quality Control 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.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- 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.
- 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.
- Manage product recalls and stock recoveries as appropriate.
- Identify compliance gaps and make recommendations for continuous improvement
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- 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!
Contact Pawel Jurkiewicz in LSC on 021 4777 329 to discuss this new role in detail or apply directly via this advert