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PurposeTo support Lab - Analytical Quality and compliance is maintained as per the GMP normsPosition / Job TitleAsst. ManagerDepartmentQuality Assurance – Analytical Lab Quality AssuranceReporting ToManager – Analytical Lab Quality AssuranceLocationAmbernathYears of Experience~12 Years Dosage FormSolid Oral / Liquid, Nasal / Injectables is preferredJob Responsibilities / Deliverables1) 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 material11) Review Analyst qualification data 12) Check rounds of lab and internal auditing13) Leading the group independently in the absence of Manager for planning and coordinating with the other functions (CFT)Qualifications & Pre-Requisites

Must-Have Skills:

- Must have knowledge on handling HPLC, GC, KF. Exposure to FT-NIR, LC/MS is additional advantage
- Exposure to various regulatory bodies like US FDA, MHRA, TGA
- Exposure to specific dosage forms like OSD, Liquid Orals, Nasal formulations is must
- Team coordination and work distribution
- Planning for the team and coordination with functions like QC, Manufacturing, Engineering, Warehouse.

Additional notes

- Role is expected to work in all shifts.
- Expected to visit to other sites on need basis.

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📌 Assistant Manager (India)
🏢 Rubicon Research
📍 India