LSC have a great contract opportunity for a Qualified person (QP) with a large biopharmaceutical company based in Cork.
If you have relevant experience in a GMP environment, a MSc and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Complies with the responsibilities of Qualified Person (QP) stated in directives issued by EC. Certifies batches for sale or supply in compliance with regulations.
- Release of Investigational medicinal Products in accordance with the requirements of Annex 13.
- Approves Annual Product Quality Review, SOPs, Complaint investigations, Deviations.
- Reviews manufacturing, environmental monitoring and quality control data for in-process and finished products.
- Works with Research and Development during new product start-ups and establishes key checkpoints for new products and processes.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Directive 2001/83/EC relating to medicinal products for human use.
- Practices (GLPs). Proficient in application of QA principles, concepts, industry practices, and standards. Demonstrates ability to effectively manage multiple projects/priorities.
- Proven analytical and conceptual skills.
- Demonstrates understanding of international quality systems regulations to adopt best in class systems/processes.
- Demonstrates excellent verbal communication, technical writing and interpersonal skills.
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! 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 Grainne Hodnett at +353 214771329 if you have any more questions about this opportunity!
