Purpose To support Lab - Analytical Quality and compliance is maintained as per the GMP norms Position / Job Title Sr. Executive

Department Quality Assurance – Analytical Lab Quality Assurance Reporting To Manager – Analytical Lab Quality Assurance Location Ambernath

Years of Experience ~10 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 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

Qualifications & Pre-Requisites Must-Have Skills:
Must have knowledge on handling HPLC, GC, KF, Dissolution. 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
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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📌 Senior Executive Ulhasnagar
🏢 Rubicon Research
📍 Ulhasnagar