Senior Associate

Job Description Summary

Review of 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 and approval of Specifications for API, Excipients, packing materials, in process, finished product and stability.
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 insruments.
Handling of Change control, CAPA.

Job Description

Review of 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 and approval of Specifications for API, Excipients, packing materials, in process, finished product and stability.

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 insruments.

Handling of Change control, CAPA.

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.