QC Biochemist: HPLC & cGLP Compliance

Sanofi; Rovigo; In loco; EUR 42.000 - 64.000; Tempo pieno

Descrizione del lavoro

Sanofi is seeking a QC professional to support testing of raw materials, intermediates, and finished products, ensuring cGLP and audit readiness. You will perform instrumental analyses (HPLC, UV-Vis, IR, Raman, etc.) and maintain rigorous documentation, contributing to digitalization and instrument qualification.

Responsibilities include coordination of external testing, data review in SAP ATHENA, and adherence to ISO 14001 and safety standards in a fast-paced pharmaceutical environment.

Competenze

• MSc in Chemistry required.
• 3 years of experience in quality control or related field.
• Basic knowledge of HPLC and instrumental analysis.
• Languages: English, Hindi, Marathi.

Mansioni

• 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 adherence and training to maintain zero risk and ISO 14001 compliance.

Conoscenze

HPLC knowledge

Instrumental analysis

Quality control

Documentation

OOS/OOT handling

Formazione

MSc in Chemistry

Strumenti

HPLC

UV-Vis

IR

Raman

Dissolution

SAP ATHENA

Descrizione del lavoro

Sanofi is seeking a QC professional to support testing of raw materials, intermediates, and finished products, ensuring cGLP and audit readiness. You will perform instrumental analyses (HPLC, UV-Vis, IR, Raman, etc.) and maintain rigorous documentation, contributing to digitalization and instrument qualification.

Responsibilities include coordination of external testing, data review in SAP ATHENA, and adherence to ISO 14001 and safety standards in a fast-paced pharmaceutical environment.