Job Description

Main purpose of the Job: * Responsible for analysis, handling of analytical (HPLC, UV & other techniques) instruments, online documentation for batch samples, Stability studies, Analytical method transfer / validations. In addition, to keep the department for compliance to the Internal/ Regulatory audits.

• Keeping the lab for anytime readiness for Internal/external Audits and overall compliance for analytical area of Quality Control who supports to the supervisor.

• Preparation of reagents and chemical as per the STP and analysis of batch samples (In-process, hold time and Drug Substance), Stability studies, Analytical method transfer / validations.
• Calibration of instruments and equipment as per the SOP / defined schedules.
• Protein analysis by HPLC, UV, SDS-PAGE, ELISA methods.
• Maintenance of Calibration of instruments and equipment as per the SOP/ defined schedules in coordination with engineering department.
• Operation of HPLC, UV spectrophotometer, gel pack and gel doc, stability chambers.
• Identify, review and compile OOS (Out of Specification), Change Control, Laboratory Incidents & Deviations.
• Participating in the internal audits and maintaining the Lab every time readiness.

• Identify, reporting and comply Lab events, OOS (Out of Specification), change control, incidents & Deviations.
• To support to the supervisor / reviewer in handle Out of Specification (OOS), Deviation, Out of Trend (OOT), Laboratory Event, Change Control, Corrective Action and Preventive Action (CAPA) with assurance of appropriate Action Plan Through Trackwise System.
• Participating in the internal/external Audits and overall compliance for Quality Control.
• Coordinating and communicating with cross functional departments like Engineering, QA, Production, Warehouse.
• Any other work assigned by reporting manager / section supervisor.

• The candidate should have good knowledge on Biopharma products and basics of all the analytical techniques and troubleshooting discussions within the team, collaboration with QA for effective closures of the investigation / events.
• Should have good writing / reading / speaking skills for effective communication, collaboration and Problem solving for deliverables.

Sun Pharmaceutical Industries