LSC have a great contract opportunity for a Quality Control Specialist to join a global Biopharmaceutical company in Carlow. This is a state-of-the-art vaccines and biologics manufacturing facility currently producing many products in various therapeutic areas including: oncology, autoimmunity, pneumonia, and infectious disease.
If you have Bachelor's Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Provide efficient support to all departments, including QC Microbiology, Quality Control and IPT for issues pertaining to LIMS, Empower and SAP, and to be a subject matter expert for these systems.
- Deliver systems training to new hires and as additional roles are required for existing personnel.
- Development and testing of systems master data. Perform new master data builds for the introduction of new products in line with analytical change control requirements to ensure the functionality is available in line with site schedule requirements.
- Liaise with Global systems working groups.
- Provide subject matter expertise in relation to Laboratory Systems. Works on improvement projects in relation to LIMS and other laboratory systems as required.
- Required to comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Considerable experience and critical skills in the area of expertise that add value to the business; ideally in Laboratory Systems setting. Preferably LIMS, Empower and SAP.
- Knowledge of data integrity requirements required.
- Change Management Skills (CEM) with continuous improvements.
- Knowledge of cGMP and GDP preferred.
- Proficiency in Microsoft Office and job related computer applications required.
- Lean Six Sigma Methodology experience desired.
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 Cathal Rourke at 0214777329 if you have any more questions about this opportunity!