Job Title: Technical Support to QC Microbiology Lab & Operations
This is an 11-month initial contract. The purpose of this role is to 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.
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:
* 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
Skills:
* Microbiology Development
* Technical Support
* Project Validation