Senior Executive

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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