QC Associate Microbiology Specialist.
We are actively recruiting for a QC Microbiology Specialist to provide technical support to the QC Microbiology Lab & operations to ensure the continued manufacture and supply of quality pharmaceutical products within a leading Pharmaceutical Manufacturing multinational.
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.
Qualifications and Experience
* Bachelor’s Degree or higher preferred; ideally in Microbiology or a closely related discipline.
* 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.
* At least 5 years’ experience in the Microbiology Pharmaceutical industry or a similar operating environment
* Strong Planning and Organising skills
* In-depth knowledge of the veterinary market
* In depth knowledge of pharmacovigilance legislation and guidelines
* Wide-ranging and sound communication skills
For more information and a full job spec contact Nicola on (phone number removed) or email your CV in the strictest confidence to (email address removed)