Job Description
This is an 11-month initial contract.
Purpose and Responsibilities
You will provide technical support to the QC Microbiology Lab & operations to ensure the continued manufacture and supply of quality pharmaceutical products in meeting the priorities of:
* Compliance, Supply, Strategy, and Profit Plan.
This role holds more senior responsibilities within the Microbiology Laboratory including (but not limited to) documentation development, report writing, execution of method and equipment validation, drug product result authorization, providing microbiological support for site, performance of bench experiments as required.
Main Objectives
1. Development and execution of Microbiology test methods and project validations.
2. Troubleshooting of issues which arise during the execution of validation studies and routine tests.
3. Development of training modules.
4. Microbiology Support to Site Investigations Driving Continuous Improvement initiatives, including lean lab initiatives, method optimization/redevelopment.
5. Authoring and managing change controls, procedures, test methods, and deviations.
6. Result authorization for microbiological samples to support batch release.
7. LIMS System updates
8. Assessing compendial and quality manual updates pertaining to the Microbiology Lab & environmental control.
9. Supporting lab stock management and financial control as required.
10. Supporting the environmental control program by trend analysis and implementation of appropriate corrective and preventative measures.
Qualifications
* Bachelors 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 Ability to work well within in a high-performance team structure Ability to work under pressure to deadlines Sound interpersonal skills for dealing with a wide range of people in a variety of situations Ability to communicate (verbally and in writing) clearly and succinctly Self-starter with drive and focus Sound commercial acumen with high levels of integrity and trustworthiness