Senior Associate Endo International
Endo International
Office Location
Full Time
Experience: 3 - 3 years required
Pay:
Salary Information not included
Type: Full Time
Location: Indore
Skills: Computer system validation, CAPA, Analytical documents review, Specifications Review, Qualification documents review, Investigation, review reports, change control assessment, Audit Trail Review, Handling of Change control
About Endo International
Job Description
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 equipments/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 equipments/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: ,