LSC have a great contract opportunity for a QC Strategy Specialist 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 8 years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Authoring of global procedures to support key analytical strategies, including training materials, training audience assignment and implementation plans.
- * Maintenance of a RAID log to support decision making, action tracking and risk socialization
- * Participation in governance forums to support decision making, endorsement and socialization, in support of the harmonization effort
- * Delivery of gap assessments, risk assessments and financial assessments to support definition of a business case for key analytical strategies
- * Support for external benchmarking as required, to ensure alignment with industry standards
- * Ensuring alignment with regulatory expectations and filed dossiers.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- * Bachelor's degree in Biological Sciences, Chemistry, or related disciplines required.
- * Advanced degree in science of pharmaceutical related fields (Chem, Pham, Bio, Chem Eng) preferred.
- * A minimum of 8 years' experience in Quality and Compliance organizations, some direct QC experience is essential.
- * Knowledge and experience in commercial analytical method lifecycle.
- * Demonstrated experience and knowledge of analytical methods (in-process, release, and stability used in late stage/commercial products), health authority regulations.
- * Experience working with an EDMS in a GMP environment.
- * Experience in working in cross functional matrix teams.
Apply via this advert or contact Kathy Gillen on 021 4777329 if you have any more questions about this role!
You will need to hold a Stamp 1G/Stamp 4 visa to apply. LSC do not provide work permit/visa sponsorship.
