Supporting and coordinating analytical transfers and routine release/stability in a dynamic, fast paced and challenging environment

Group Leader responsibilities within the Microbiology group include;•Review and approval of analytical reports and test results;•Writing and executing validation/verification protocols for commercial products, product transfers and cleaning/hold time studies;•Initiation, investigation and reporting of out of specification events;•Coordinating routine and non-routine environmental monitoring and water sampling across the site;•Compiling annual and quarterly environmental and water reports;•Closure of events, investigations and commitments.

• Work in a controlled, regulated environment adhering to cGMP and GLP on a daily basis;• Aseptic testing of purified water, media and Environmental samples:• Aseptic QC Testing of raw materials, intermediates and finished products;• Identification of microbial contaminants – Gram staining and Vitek;• Training of analysts and operators within the QC Department and in Operations;• 5S auditing of other QC laboratories.

• Routine bioburden, growth promotion and water testing;• Customer complaint investigation & resolution;• Formulation of testing media;• Creation, implementation and updating Standard Operational Procedures• Routine calibration of laboratory equipment;