LSC have a great contract opportunity for a QC Materials Technical Lead 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 5+ years industrial experience and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Develop, maintain and oversee the sample management lab programs for the Drug Substance and Drug Product facilities.
- Oversee the QC VMI program, driving a lean capacity and keeping expiry losses at a minimum.
- Support the review and approval of Material Science & Technology (MS&T) Drug Substance & Drug Product study protocols & reports as the Sample Management subject matter expert (SME).
- Provide SME support on QC, Manufacturing and Warehouse investigations involving QC sample components, including impact assessment, root cause analysis and Corrective/Preventative Action generation.
- Participate in and support audits, both internal and external (HPRA/FDA etc.) Act as the primary point of contact for audit discussions relating to sample management.
- Build and foster strong relationships within the biologics quality and global quality network to drive compliance, strengthen quality systems and support company objectives. Collaborate with network sites on technical issues to drive and maintain an aligned quality approach and foster an environment of continuous improvement
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- A minimum of a B.Sc. in Biochemistry or related discipline and must have at least 5 years' experience, in a GMP laboratory setting with sample management experience.
- Knowledge of cGMPs pertaining to sample management.
- Understanding of the needs and best practices of routine biopharmaceutical drug product and drug substance laboratories is desirable.
- Demonstrated ability to influence work cross functionally in a dynamic and challenging environment.
- The candidate must have experience in electronic systems such as LIMS/CIMS, Trackwise/Infinity and SAP.
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.
Apply via this advert or contact Sarina Abdulha on 021 4777 329 if you have any more questions about this opportunity!
