Senior Research Associate-AD

• Prepare trending of Events/Incident and ensure completeness of its closure. Identify the gaps and provide appropriate training to analytical scientist to strengthen compliance level.
• Thorough review of clinical batch release data, method validation protocol & report, clinical stability sample analysis, as per cGMP and regulatory requirement.
• Ensure review of daily verification/calibration of pH meter, balances and TOC.
• Ensure review of calibration record of all analytical instruments and update of calibration planner in timely manner.
• Thorough review of method development report and investigation study report
• Randomly review and cross verify all analytical instrument logbook entries and laboratory notebook for its completeness for compliance point of view.
• Randomly review of standard, column and chemical management logbooks.
• Ensure in-house compliance system.
• Randomly review of QMS activities (i. e. change control, incident, deviation).
• Maintain hygienic condition in laboratory.
• Follow GxP (GMP, GDP, GLP) for all processes.
• Ensuring proper use of Personal Protective Equipment.
• Thorough review of IQ/OQ and PQ of instrument/equipment.
• Ensure computer System Validation according to CSV SOP and identify gap in qualification document according to CSV SOP.
• Perform internal audit of AD and provide appropriate training to AD team.
• Accompany the internal audit and provide appropriate response to audit observations.
• Training on GDP/GLP/DI to the scientist on quarterly basis to ensure compliance.
• Tracking and monitoring of calibration planner and preventive maintenance planner.

M. Pharm/ M. Sc. Chemistry