LSC have a great contract opportunity for a Qualified Person (QP) to join a Dublin based Biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that can help patients overcome serious diseases and improve their quality of life.
If you have 10+ years industrial experience and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Qualified Person certification and batch release of clinical supplies
- Acts as a Responsible Person on a WDA for Pre-Approval Access
- Support for Health Authority GMP/GDP inspections and audits across the supply chain
- Advise stakeholders on quality issue management and process enhancement/compliance - ensuring consistent quality standards and fostering strong working relationships
- Incorporate global regulatory trends and changes into Supply Chain Quality
- Site master file maintenance
- Manufacturers Authorisation update and maintenance
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- A degree in science, engineering or related discipline is essential along with 10 years' experience in a role within the biopharmaceutical/pharmaceutical industry
- Must be eligible to act as Qualified Person on the Manufacturing/Importation Authorisation
- Previous experience as a Responsible Person on a WDA is preferred
- Demonstrated strong knowledge of ICH/GMP, data integrity, regulatory guidelines/directives, clinical supply chain processes and principles of Quality Assurance
- Proven track record of building/ maintaining high-performance teams/organizations and influencing/ motivating global teams to achieve results-delivering on business and program goals
Applicants interested in our contracting opportunities within the pharmaceutical sector in Ireland are required to have a Stamp 1G or a Stamp 4 visa. Please understand that we are unable to provide visa sponsorship. Thank you for your understanding.
Apply via this advert or contact Siobhan Cummins on 021 4777 329 if you have any more questions about this opportunity!
