LSC has 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. 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:
* 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.
* Perform and review complaints and deviation investigations, change controls, and CAPAs.
* Create and maintain assigned SOPs.
* Compile data for reports and presentations, provide data interpretation, and draw conclusions.
* Represent the department on cross-functional teams.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
* The Specialist is required to possess a degree in a Science or Engineering discipline plus some industrial experience.
* Alternatively, they must possess considerable 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 if you have any more questions about this opportunity!
Skills:
GMP, Quality, Compliance, Batch records, QP
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