Endo Hiring for Quality Assurance Associate / Sr Associate (Mumbai) at Ghatshila, Jharkhand, India Full Time

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.