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,

- Retention sample management, stability management & review of stability protocol/summary sheet
- Computer system validation, glassware cleaning validation, calibration & qualification of instruments
- Review of audit trail.
- Ensure all time laboratory compliance.
- Handling of QMS records like OOS/OOT, CAPA, Change Control, Deviation and making the trend reports.
- Review of analytical documents which include worksheet, chromatograms, AMT/AMV.
- Preparation, Review of specification & STP.




- To review the Analytical reports in support of Batch release activities
- To review and approve the Certificate of Analysis received from QC for Finished Product, Raw material, Packing material
- Review Analyst qualification data
- Check rounds of lab and internal auditing
- 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 (Ulhasnagar)
🏢 Rubicon Research
📍 Ulhasnagar