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Qualified person

Dublin
Life Science Consultants (LSC)
Posted: 11 December
Offer description

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 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.

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