LSC have a great contract opportunity for a Quality Specialist to join a top 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 Science or Quality and are ready for your next challenge, this could be the perfect project for you!
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.
- Manage product recalls and stock recoveries as appropriate.
- Perform and review complaints and deviation investigations, change controls and CAPA's.
- Carry 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.
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.
- 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
Please note that for our contracting opportunities in the pharmaceutical sector in Ireland, candidates must possess either a Stamp 1G or a Stamp 4 visa. We regret that we are unable to provide visa sponsorship at this time. Thank you for your understanding.
Apply via this advert or contact Gráinne Hodnett on 021 4777 329 if you have any more questions about this opportunity!
