Job Description Summary
Responsible for review of Microbiological documents of method validation/method development for Sterility, BET, AET, PMT tests for injectable finished products and method development documents (API’s, Excipient) for BET and MLT tests .
Responsible for review of documents for Diluent compatibility studies.
Responsible for review of miscellaneous study protocol and report related to microbiology Lab/ analytical Lab facility.
Responsible for review of documents for laboratory equipment qualification/calibrations, water system qualifications, HVAC requalification data, gowning qualification data etc.
All incumbents are responsible for following applicable Division & Company policies and procedures.
Job Description
Job Description :-
- Responsible for review of Microbiological documents of method validation/method development for Sterility, BET, AET, PMT tests for injectable finished products and method development documents (API’s, Exepient) for BET and MLT tests.
- Responsible for review of documents for Diluent compatibility studies.
- Responsible for review of miscellaneous study protocol and report related to microbiology Lab/ analytical Lab facility
- Ensuring compliance of all SOP and system implementation.
- Responsible for review of documents for laboratory equipment qualification/calibrations, water system qualifications, HVAC requalification data, gowning qualification data etc.
- Responsible for review of all analytical instrument (Autoclave, Incubators, water Bath, steam pot , balances etc.) calibration records.
- Responsible for review of QMS activities, and ensure all time compliance to cGMP requirements, ensure to follow all GDP practice.
- SOP, QMS, Logging for QMS and issuance of formats,& documentation for Analytical Laboratory
- Maintain good documentation practices.
- Documentation support for Analytical Lab.
- Technical support for Analytical Lab
Education & Experience :-
M.Sc. Microbiology with 3-8 years of related experience.
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.
Top Skills
What We Do
At Endo, our far-reaching vision is simple: to help everyone we serve live their best life. As a specialty pharmaceutical company, we’re motivated by a strong sense of purpose to find better ways to meet unique medical needs.
Our global team of passionate employees understands the importance of their work. We’re dedicated to supporting one another as we connect with communities and foster partnerships that elevate quality-of-life and bring the best treatments forward.
Our uncompromising commitment results in the delivery of life-enhancing therapies. From intelligent product selection to commercialization, we strive to make a meaningful, tangible impact to help everyone live their best life.
Endo has global headquarters in Malvern, Pennsylvania.
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