LSC have a great contract opportunity for a Sr Associate QC to join a South Dublin based Biopharmaceutical company that specialises in secondary manufacturing activities such as Formulation, Fill Finish and Packaging.
If you have a minimum of 3 years of laboratory experience in a cGMP laboratory environment including exposure to analytical instrument validation and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Planning, executing and documenting the qualification of new laboratory equipment in a cGMP regulated environment.
- Developing and maintaining an equipment qualification project plan, as part of the commissioning of new laboratory facilities.
- Development of laboratory equipment specifications to be used for procurement of new laboratory equipment and instruments.
- Writing equipment validation protocols and associated summary reports.
- Maintaining a current working knowledge regarding regulatory requirements for equipment qualification and calibration.
- Generation and resolution of protocol discrepancies as required.
- Alerting Quality Control Management if equipment fails to meet calibration or qualification requirements and conducting impact assessments/investigations as required.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Knowledge of the methodology and instrumentation and analytical techniques used for biopharmaceutical testing.
- Understanding of current regulatory requirements for cGMP laboratory equipment validation and electronic record integrity.
- Demonstrated success in managing an equipment qualification or maintenance program advantageous.
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 Sr Associate QC opportunity!