Description
The Role - QC Microbiology TechnicianDuration - 9 months
Location – Co. Carlow
Job Summary
Responsible for quality control of the environmental, utility monitoring programs to ensure compliance with client's internal and worldwide regulatory standards. Carrying out routine testing and test method validation/qualification of drug product for microbiological/chemical attributes, as required. Participate in all Quality-related functions that directly support the Integrated Process team (IPT) and the site value stream map. Ensure that objectives are effectively achieved, consistent with client's requirements to ensure compliance, safety and reliable supply to our customers.
Principal Accountabilities:
- Perform environmental monitoring, water monitoring, lab support testing including identification of Isolates, Bioburden and Endotoxin testing, in accordance with GLP, GMP and regulatory requirements. This includes document generation and review as identified by the Microbiology Laboratory Coach.
- Perform testing of drug substance and drug product in accordance with the validated methods, ensuring compliance to regulatory filings. Performing method qualifications/validations of new products in line with site Plan of Record.
- Support process simulations by performing inspection, reconciliation and growth promotion testing as required.
- Support/perform environmental monitoring of clean rooms and controlled environments. Preparation of trend reports for review by QA Lead Technician/Micro Lab Coach as applicable and other associated groups.
- Support and comply with safety and compliance initiatives on site.
- Support/perform media growth promotion and maintenance of Stock Cultures.
- Operation of laboratory equipment and stock levels and perform general housekeeping activities.
- Participate in training and personal development opportunities identified by the Microbiology Laboratory Coach
- Participate in effective writing/revising/ rolling out of accurate operational procedures, training materials and procedures for various Quality systems; ensure all work is subsequently carried out in line with same.
- Actively participate and promote continuous improvement in the Microbiology Laboratory by leading and active participation in system failure investigations and investigation reports, execution/development of change control, and contribution to Kaizen events as appropriate. Manage root cause analysis of system failures, substandard equipment performance, using standard tools and methods, to resolve system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.; oversee and implement subsequent corrective action through the change management system.
- Required to comply with Merck 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.
- Work collaboratively to drive a safe and compliant culture.
- May be required to perform other duties as assigned.