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.
