Job Summary:
We are currently recruiting for an exciting opportunity with a leading Pharmaceutical organization. This role holds more senior responsibilities within the Microbiology Laboratory, including documentation development, report writing, and execution of method and equipment validation.
Key Responsibilities:
* Development and execution of Microbiology test methods and project validations.
* Troubleshooting of issues which arise during the execution of validation studies and routine tests.
* Development of training modules.
* Microbiology Support to Site Investigations
* Driving Continuous Improvement initiatives, including lean lab initiatives, method optimization/redevelopment.
* Authoring and managing change controls, procedures, test methods and deviations.
* Result authorization for microbiological samples to support batch release.
* LIMS System updates
* Assessing compendial and quality manual updates pertaining to the Microbiology Lab & environmental control.
* Supporting lab stock management and financial control as required.
* Supporting the environmental control program by trend analysis and implementation of appropriate corrective and preventative measures.
Requirements:
* Bachelor's Degree or higher in Microbiology or a closely related discipline.
* 5 years experience in the Microbiology Pharmaceutical industry or a similar operating environment.
* Demonstrated change management skills (CEM) with continuous improvement.
* Strong knowledge in execution, validation and development of microbiology related test methods i.e. Bioburden, Endotoxin and Sterility testing.
Skills:
* Microbiology
* GMP Validation