Job Description
We are seeking a highly skilled QC Microbiology Specialist to provide technical support to the QC Microbiology Lab and operations. The successful candidate will play a crucial role in ensuring 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 arising during validation studies and routine tests.
* Development of training modules for staff members.
* Microbiology Support to Site Investigations, driving Continuous Improvement initiatives.
* Authoring and managing change controls, procedures, test methods, and deviations.
* Result authorization for microbiological samples to support batch release.
* LIMS System updates and assessments of compendial and quality manual updates.
* Supporting lab stock management and financial control as required.
* Supporting the environmental control program through trend analysis and implementation of corrective measures.
Qualifications and Experience:
* Bachelor's Degree or higher in Microbiology or a closely related discipline.
* Demonstrated change management skills with a focus on continuous improvement.
* Strong knowledge of microbiology-related test methods, including Bioburden, Endotoxin, and Sterility testing.
* At least 5 years of experience in the Microbiology Pharmaceutical industry or a similar operating environment.
* Strong Planning and Organising skills, with in-depth knowledge of pharmacovigilance legislation and guidelines.
* Sound communication skills with ability to work effectively in a team environment.