Assistant Manager
Posted Updated
Description
Job Description
| Purpose | To support Lab - Analytical Quality and compliance is maintained as per the GMP norms |
| Position / Job Title | Asst. Manager |
| Department | Quality Assurance – Analytical Lab Quality Assurance |
| Reporting To | Manager – Analytical Lab Quality Assurance |
| Location | Ambernath |
| Years of Experience | ~12 Years |
| Dosage Form | Solid Oral / Liquid, Nasal / Injectables is preferred |
| Job Responsibilities / Deliverables | 1) Well versed in the analytical review which includes review of GLP, Lab support systems like Column management, Standard handling, 2) Retention sample management, stability management & review of stability protocol/summary sheet 3)Computer system validation, glassware cleaning validation, calibration & qualification of instruments 4) Review of audit trail. 5) Ensure all time laboratory compliance. 6) Handling of QMS records like OOS/OOT, CAPA, Change Control, Deviation and making the trend reports. 7) Review of analytical documents which include worksheet, chromatograms, AMT/AMV. 8) Preparation, Review of specification & STP. 9) To review the Analytical reports in support of Batch release activities 10) To review and approve the Certificate of Analysis received from QC for Finished Product, Raw material, Packing material 11) Review Analyst qualification data 12) Check rounds of lab and internal auditing 13) Leading the group independently in the absence of Manager for planning and coordinating with the other functions (CFT) |
Qualifications & Pre-Requisites | Must-Have Skills:
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Additional notes |
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