QC - Assistant Manager

USV PRIVATE LIMITED; Daman; On-site; INR 800,000 - 1,100,000; Full time

Job summary

USV PRIVATE LIMITED is seeking a Laboratory Operations professional to oversee the QC Raw Material section, manage daily testing activities and release APIs, excipients, and packaging materials to support production schedules.

You will lead data review of analytical results (HPLC, GC, FTIR, UV-Vis, Karl Fischer, Auto-Titrators) and drive laboratory investigations for OOS/OOT, CAPA implementation, and change controls while maintaining ALCOA+ data integrity across electronic systems such as

Responsibilities

• Laboratory Management: Oversee the daily operations of the QC Raw Material section, including work allocation, shift planning, and ensuring the timely testing and release of APIs, excipients, and packaging materials to support production schedules.
• Data Review & Approval: Perform secondary review of analytical test data, chromatograms, and audit trails generated from sophisticated instruments (HPLC, GC, FTIR, UV-Vis, Karl Fischer, Auto-Titrators) for accuracy and compliance.
• QMS & Investigations: Lead laboratory investigations for Out of Specification (OOS), Out of Trend (OOT), and routine deviations. Implement effective Corrective and Preventive Actions (CAPA) and evaluate change controls related to the RM section.
• Compliance & Data Integrity: Ensure strict adherence to ALCOA+ principles and Data Integrity guidelines across all laboratory operations. Monitor electronic data systems (e.g., Empower 3) and ensure contemporary documentation practices.

Job description

• Laboratory Management: Oversee the daily operations of the QC Raw Material section, including work allocation, shift planning, and ensuring the timely testing and release of APIs, excipients, and packaging materials to support production schedules.
• Data Review & Approval: Perform secondary review of analytical test data, chromatograms, and audit trails generated from sophisticated instruments (HPLC, GC, FTIR, UV-Vis, Karl Fischer, Auto-Titrators) for accuracy and compliance.
• QMS & Investigations: Lead laboratory investigations for Out of Specification (OOS), Out of Trend (OOT), and routine deviations. Implement effective Corrective and Preventive Actions (CAPA) and evaluate change controls related to the RM section.
• Compliance & Data Integrity: Ensure strict adherence to ALCOA+ principles and Data Integrity guidelines across all laboratory operations. Monitor electronic data systems (e.g., Empower 3) and ensure contemporary documentation practices.