LSC have a great contract opportunity for a Senior QC Associate to join a South Dublin based Biopharmaceutical company that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging.
If you have 3+ 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:
- Provide laboratory business administration, implementation and technical support for QC systems including LIMS (Thermo SampleManager), Biovia SmartLab (LMES), Biovia CIMS and Empower.
- Build, develop and maintain LIMS templates and support LMES eProcedure implementation, including CIMS and SOP updates.
- Provide end-user support and training for QC laboratory applications and work closely with site Business Process Owners and laboratory SMEs.
- Review and approve Quality Documentation including sample plans, FORMs and Environmental Monitoring sample plans.
- Contribute to Computer System Validation and Data Integrity activities in line with GAMP 5, Annex 11, PIC/S and 21 CFR Part 11 requirements.
- Support continuous improvement initiatives for laboratory applications as well as audit and inspection preparation and participation.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Third-level qualification in a Science-related discipline with 3+ years' experience in a Biotechnology, Pharmaceutical or GMP-regulated environment.
- Previous experience using LIMS, LMES, CIMS and/or Empower, with knowledge of QC laboratory operations and analytical laboratory techniques.
- Knowledge of cGMP, Computer System Validation, Data Integrity Assessments and 21 CFR Part 11 requirements for computerised systems.
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Apply via this advert or contact Kathy Gillen on 021 4777329 if you have anymore questions about this role!
