Role Purpose
Protect the end users of products manufactured in the compounding unit by maintaining an appropriate level of regulatory compliance. To design, effectively implement, monitor and maintain the quality management system. Ongoing management of licenses related to specials manufacture and management of Competent Authority inspections and customer audits. Manage the QA team to deliver its objectives.
Key Deliverables
- Responsible for ensuring effective sterility assurance and environmental monitoring programmes are deployed in compliance with current GMP.
- Supporting sterility assurance practices and identification/implementation of new technology for microbiological testing and environmental control.
- Participation in continuous improvement projects and providing expert guidance and assessment for the questions related with sterility insurance, including risk reduction initiatives in line with company strategy.
- Support and lead problem solving investigations for product and process deviations or customer complaints
- Provide coaching and mentoring to other functions in problem solving with respect to Sterility Assurance
- Participate in compounding complaints investigation, nonconformance and quality incidents investigation, act as technical approver
- Provide technical support in interpretation of Microbial identification and environmental monitoring data for the trending of EM and Microbiological data including setting of appropriate Alert limits
- Responsible for the tracking and reporting or Quality Metrics for internal and external use
- Carry out validation and experimental design in association with EMEA Sterility Assurance Manager
- Qualification, Auditing and monitoring the service levels of external lab, providing the roper oversight on technical aspects
- Support the development of the quality documentation including SOP's
- Providing Microbiological training and Aspetic Operator Training for operational and quality staff including periodic reassessment
Your Skills & Knowledge
- Required 3 years' experience in implementing environmental control programs and OOL investigation and correction
- Preferred 5 years' experience of microbiology experience in an aseptic facility
- Must have strong operational experience preferably in an aseptic manufacturing background
- Experience of Aseptic technique
- Have experience in the use of quality improvement and problem-solving skills (FMEA, DMAIC, Process Mapping etc) and the interpretation of data, experience of Lean Manufacturing
- Have experience of critical equipment and process change control
- Have experience of validation of microbiological methods or sanitization processes
Education:
- Degree in Microbiology, although others may be considered with relevant experience