Sr Analyst

3 weeks ago

indore, India Endo Full time

Job Description Summary

1.Responsible for preparation and review of Analytical method validation protocols for MLT, BET, Sterility, Container Closure Integrity Testing, Bioburden and other Microbiological methods.
2.Responsible for sample management, media and culture management including Microbial Identification on Vitek System.
3.Responsible for Maintaining Laboratory Analytical review of Documents and timely submission of Laboratory documents for Archival.
4.Trouble shooting and supervision of team members involved in sample management, media and culture management related testing activities.
5.Responsible for maintaining, reviewing and evaluation of GLP compliance in laboratory and take effective measures as a continuous improvement program.
6. Execution of BET by KTA and Gel-clot method, Particulate matter testing.

Job Description

1. Responsible for Microbiology operation and implementation of approved procedures in Laboratory.

Responsible for sample management, media and culture management.

2.Responsible for preparation and review of Analytical method validation protocols for MLT, BET, Sterility, Bioburden and other Microbiological methods.

3.Responsible for Maintaining Laboratory review of Documents and timely submission of Laboratory documents for Archival.

4. Ensure timely completion of method validation of all the samples.

5. Coordinate with cross functional team for planning and effective execution of Method Validation activities and support manufacturing related activities in Microbiological studies.

6.Responsible for maintaining, reviewing and evaluation of GLP compliance in laboratory and take effective measures as a continuous improvement program.

7. Trouble shooting and supervision of team members involved in sample management, media and culture management related testing activities.

8.Review and submission of document to regulatory department for filling and regulatory approvals.

9.Support and participate in internal, customer and regulatory inspection and ensure appropriate CAPA initiated and implemented.

10.Evaluate and approve change control, deviations and CAPA raised by Microbiology department and other departments and identify actions to be implemented.

11.Ensure monitoring of utilities required for manufacturing process as per approved schedule and carryout data trending and analysis.

12.Participate in quality improvement programs and support QA function to execute quality related projects.

13. Prepare departmental budget and maintain adequate inventory of consumables.

Commitment to Diversity, Equity, and Inclusion:

At Endo, our diversity unites and empowers us as One Team, and we are committed to cultivating, and valuing, each person’s unique perspective. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity, including race, ethnicity, religion, gender identity or expression, national origin, color, sexual orientation, disability status, age, and all our other unique characteristics, qualifications, demonstrated skills, achievements, and contributions, backgrounds, experiences, cultures, styles, and talents.

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