Quality Control Biochem
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Overview
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In this role, you will support quality control testing of raw materials, intermediates, and finished products to ensure compliant release and stability data. You will work within Sampling & Analysis to uphold cGLP, perform instrumental analyses (HPLC, GC, UV-Vis, etc.), and maintain rigorous documentation and audit readiness. You'll contribute to digitalization efforts and instrument qualification while ensuring safety and regulatory compliance in a fast-paced pharmaceutical environment. This is an opportunity to help Sanofi deliver life-changing medicines at scale from Goa.
Responsabilità
- Sampling and handling of Raw Material, intermediate and finished products as per SOPs
- Managing sample storage and external testing coordination
- Performing analysis of RMs, intermediates, stability samples, and finished goods per specs
- Ensuring cGLP in laboratory activities and audit readiness
- Instrumental analysis (HPLC, GC, UV-Vis, IR, Raman, Dissolution, etc.)
- Documentation: raw data, ATR records, logbooks, calibration and qualification documents
- Reviewing and revising test procedures; raising deviations and CAPAs via Qualipso
- Result recording and data review in SAP ATHENA; instrument qualification
- Support on digitalization and simplification of QC activities; address OOS/OOT deviations
- Carry out instrument calibration, preventive maintenance, and method validation
- HSE xysqume adherence and training to maintain zero risk and ISO 14001 compliance
Requisiti fondamentali
- MSc in Chemistry
- 3 years of experience in quality control or related field
- Basic knowledge of HPLC and instrumental analysis
- Languages: English, Hindi, Marathi
- Raw material testing
- Finished product testing
- Instrument handling (HPLC, UV-Vis, IR, Raman, Dissolution, etc.)
- SOP adherence and regulatory documentation
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