Microbiology Supervisor

KEYVAC BİYOLOJİK ÜRÜNLER SAN. VE TİC. A.Ş

Job Requirements:

·       Graduation from Biology Departments of universities,

·       Advance level of English Language Skills,

·       Minimum of 5 years of experience in cGMP Quality Microbiology Laboratory.

·       Experience in managing/leading teams preferential.

·       Experience in testing of sterile drug product and aseptic filling process of sterile pharmaceutical/biopharmaceutical products.

·       Good knowledge of current regulatory requirements for QC.

Job Responsibilities:

·       Lead a team of analysts in QC Microbiology Laboratory by coordinating daily operations and ensuring tasks are complete to meet business needs.

·       Support cleaning validation activities on site.

·       Lead a team of analvsts to schedule real time review and ensure it is complete to support business needs.

·       Ensuring high cGMP, GLP standards are maintained while testing.

·       Support validation/verification and qualification of test methods and processes.

·       Support equipment qualification as required.

·       Lead and participate Quality Risk Assessments relating to QC.

·       Facilitate laboratory investigations and support associated product investigation.

·       Represent the QC department in internal and external audits where appropriate.

·       Troubleshoot laboratory methods and instrument problems.

·       Perform technical review of data generated in laboratory, validation protocols and reports.

·       Completion of project work and implementation of initiatives designed to improve the efficiency of the laboratory function/department.

·       To ensure a high standard of housekeeping is maintained in the Laboratory.

·       To maintain competence and keep up to date with all new technologies, procedures and methods used in the QC Laboratories.

·       Investigate out of specification/limit results utilizing.

·       Structured Problem Solving, Root Cause Analysis tools in conjunction with the QC Manager, QA and other relevant departments and to implement effective corrective and preventative actions.