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Lupin
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Officer

Officer

Lupin

2 - 7 years

4 - 7 Lacs

Pune

Posted:1 month ago| Platform:

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Skills Required

method validation risk assessment market complaints ipqa bmr hplc change control oos sop oot qms api calibration chemistry capa uv equipment qualification quality control bpr documentation deviation process validation quality assurance cleaning validation bpr review

Work Mode

Work from Office

Job Type

Full Time

Job Description

Job Description 1. Preparation of SOPs of QA, review of other departments' SOPs, 2. To perform batch release of API material and review of related documents. 3. To prepare and review Quality Risk Assessment, Site Master File, Hold Time Study Protocol/Reports, and other study protocols/reports, Specifications, Stability Protocol, and Stability Report Data. 4. Review of Validation Master Plan. 5. To review the analytical method transfer protocol/report and method validation documents of the API. 6. To ensure and handle the investigation of out-of-specification Results, OOT, Deviations, Product failures, and Market Complaints. 7. To review Quality system documents such as Deviation, Change control, CAPA, OOS, OOT, re-processing, Re-work, market complaints, and market returns. 8. To review Qualification Protocols/Reports of product, equipment, and facility. 9. To Review of the Annual Product Quality Review. 10. To review of Master Document, such as BPR, Test and Calibration Data Sheet, Test Procedures, and Microbiological Test Procedures. 11. To collect, review, and submit documents to the RA Department for dossier preparation /Regulatory Submission. Work Experience 5 to 8 Years Education Post Graduation in Chemistry Competencies

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