LSC have an exciting opportunity for Qualified Person (QP) with a Dublin based state-of-the-art biologics manufacturing technology. As a Qualified Person (QP), you'll be at the forefront of ensuring product quality and compliance in a dynamic, global environment. The role provides extensive exposure to various aspects of clinical supply chain operations, fostering continuous learning and professional growth
ABOUT THE ROLE:
This is your chance to be part of a cutting-edge biologics manufacturing facility that's shaping the future of healthcare. As a Qualified Person (QP), you'll play a crucial role in ensuring the highest quality standards in clinical supply chain operations.
PRIMARY RESPONSIBILITIES
- Perform Qualified Person (QP) certification and release activities for clinical trial supplies
- Conduct audits of internal GMP systems/processes and suppliers/third-party contractors
- Provide regulatory advice and manage regulatory agency inspections
- Support start-up activities for Clinical Supply Chain Quality Dublin
- Oversee Manufacturer(s)/Importation Authorisation submissions and maintenance
- Participate in multidisciplinary teams and contribute to strategic initiatives
ARE YOUR SKILLS A MATCH?
- Degree in science, engineering, or related discipline
- 10+ years of experience in the biopharmaceutical/pharmaceutical industry
- Eligibility to act as a Qualified Person (QP) on the Manufacturing/Importation Authorisation
- Strong knowledge of ICH/GMP, data integrity, and regulatory guidelines
- Proven leadership and influence management skills
- Excellent communication abilities and partnership-building capabilities
Please apply directly via this advert or contact Kathy Gillen on 021 4718212 to discuss this opportunity in more detail.
All applicants must have a valid work permit for at least 12 months. LSC do not offer work permit or visa sponsorship.
