Job Description Summary

QA Asst Manager (Micro)

Job Description

Review of Microbial analytical documents of Raw materials, packing materials, In process, Hold time, finished product, stability, Analytical method transfer/Validation/Verifications protocol, reports, and raw data.

Review of qualification documents (IQ/OQ/PQ) of equipment’s/instruments.

Investigation and review reports of laboratory OOS, OOT, Incidents. Discussion of QMS action points with CFT and to make sure the closure within TCD.

Provide support in assessing Change Control requests. A

Computer System Validation (CSV) deliverable preparation/review.

Audit trail review of laboratory instruments.

Handling of Change control, CAPA.

Should have minimum 10-14 years of work experience in Microbial Analytical activities.

Should be aware about QMS procedures.

Should be aware about software compliance and audit trail review.

Should be knowledgeable on guidelines per regulatory requirements, e.g., ICH, US FDA, 21 CFR,

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.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.