The role is to be part of a small team of microbiologists, ensuring compliance of controlled environments and ensuring control of manufactured products through bioburden and VD Max testing. Support site development projects by ensuring control standards are maintained. Embrace and drive Convatec's core mission, values, and priorities., General
- Ensure facilities, processes, personnel, and materials/products are microbiologically tested in line with cGMP and procedural requirements
- Prepare Microbiological media/agar and carry out Quality control checks
- Water sampling and Microbiological water testing
- Perform Environmental monitoring within the controlled environments
- Perform routine product bioburden testing
- Microscopic Gram staining
- Provide microbiological support for Operations
- Ensure testing is conducted in an aseptic manner and the microbiology lab is kept in a clean, organised condition
- Collect trend data, react to trends and report to Team Lead. Manage out-of-specification results, facilitate laboratory investigations and involve the site Quality Director where applicable.
- Maintain laboratory metrics
- Ensure compliance is maintained as directed by Notified Bodies regulations
- Comply with GMP/GLP requirements and uphold these standards
- Comply with EHS requirements and uphold these standards
- Maintain validation of Microbiology test methods,
- Ensure maintenance of the operational equipment within the lab.
EHS
- To meet the safety, health, and environment policy.
- Keep information on the Convatec EHS policy and the regulations that support it.
- Be aware of workstation risks, respond appropriately, and communicate them to the responsible manager.
- To support continuous improvement in the EHS areas by making recommendations on improvements to the responsible manager
- Experience of ISO11737, 11137,11135, 17665, and Pharmacopeia references is desirable
- Understanding of GMP and Quality Systems in a regulated environment.
Qualifications/Education
- Educated to degree level, or equivalent, within a Microbiological discipline
- Demonstrated experience within a microbiology laboratory
Languages
- Mandatory spoken and written English
Working Conditions
- Working in a laboratory and clean room environment as well as an office in Deeside, Wales