LSC have a great contract opportunity for a QC Compliance Specialist to join a Cork based Biopharmaceutical company.
If you have at least 2 years' experience in a Quality role in a GMP environment and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
o Provide quality support for QC, and act as point of contact for QC Compliance as required.
o Provide technical support and apply expertise and critical thinking to help resolve technical and compliance issues.
o Lead Quality risk assessments, FMEAs and other quality tools to help maintain product quality and patient safety.
o Lead/Support data mining exercise to collate complex data and present this data in a clear and concise manner.
o Monitor changes to external health authority regulations, pharmacopoeias and industry best practices and ensuring that these changes are assessed across the relevant business functions and changes implemented where necessary.
o Support the QC department in management of the end to end process for inspection preparation, inspection management and response to inspection findings and tracking of associated actions, ensuring best practices are implemented and employees fully educated in the inspection management system and processes.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
o Knowledge of regulatory requirements, current cGMP standards and practices.
o Proficiency in Microsoft applications
o Experience in QC analytical systems, Trackwise, Lean Six Sigma, LIMS desirable
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 Aoife Gleeson at LSC on 021-4777329 if you have anymore questions about this QC Compliance Specialist opportunity!