Address The Associate Director, Global Quality Control LTS Microbiology is responsible for directing and managing compliant, effective, and efficient operations of Laboratory Technical Services (LTS)-Microbiology group globally and accountable for development of rugged & robust methods, validation of methods, transfer of validated methods and managing complex microbiological prefiling studies for injectables molecules for all Endo sites.
This position is also accountable for Microbiology function at Analytical Lab, Digha operating in-line with the Endo values to foster a culture of Quality, Compliance and Excellence.
This position is also accountable for Microbiology function at Analytical Lab, Digha operating in-line with the Endo values to foster a culture of Quality, Compliance and Excellence.
Job Description:-
- Ensure on-time support for microbiological prospects to R&D teams for development of Sterile injectable products.
- Ensure that teams develop rugged and robust methods, methods are validated and stability indicating for injectable / complex injectable drug products.
- Ensure that the microbiological methos are transferred to manufacturing sites as per project timelines.
- Provide expert inputs during development and validation of complex microbiological methods and troubleshooting.
- Evaluate Global LTS Microbiology and Digha site Microbiology operations strategically to ensure that the functions are operated in accordance with highest quality standards.
- Ensures staff is fully trained on GxP laboratory operations, good documentation practices and adhering to safety guidelines. Build effective teams applying diverse skills and perspectives to achieve common goals.
- Directs and monitors QMS elements (Laboratory investigations, OOS investigations, Deviations, CAPA), Interpretation/Presentations, statistical analysis, and trending within the function.
- Directs and oversee Global LTS Microbiology and Digha Microbiology lab operations, creating competent & technical human resources that embody ENDO’S values.
- Oversee and provide strong guidance to managers for the performance of functional operations, people management and collaboration.
- Promotes culture of speaking up and seeks to embody Endo’s Values
Education & Experience
- Bachelor’s or Mater’s degree in Microbiology or related discipline with 14 + years of experience in Pharmaceutical Microbiology with sterile products.
- 5+ years’ managerial experience in pharmaceutical industry is highly preferred.
