SOP review of departments, monitoring its compliance, and circulation of SOP review status
To prepare and review SOPs related to TFM and Quality Assurance
To verify that the study plan and amendments contain the information required for compliance with the Principles of OECD Good Laboratory Practice (GLP) and documentation of the verification
To conduct study-based inspections to determine that studies are conducted in accordance with OECD Principles of GLP, to perform facility-based inspections, and circulation of facility review status to departments and TFM
To review the final reports to confirm that the methods, procedures, and observations are accurately and completely described and that the reported results accurately and completely reflect the raw data of the studies
To document and promptly report any inspection results in writing to the management, study director, PI (wherever applicable), Lead QA (wherever applicable), and to the respective management.
To prepare and review the Quality Assurance Statement as per Principles of OECD GLP.
Communicate with the study director, PI (wherever applicable), for the inspection schedule and identification of the critical phases of the study.
Ensure that all issues raised in the QA audit/inspection have been appropriately addressed and all agreed actions have been completed.
To review the deviation, and incident reports and to ensure the proper corrective and preventive actions have been taken.
To review the validation documentation of the computerized systems and instruments qualifications.
To verify the valid use of computerized systems and to include procedures and practices that verify if established standards are met for all phases of a system’s life cycle.
To participate in laboratory supplier/Vendors and CRO qualification.
To review the floor plans and organizational charts for departments within the facility.
To review ATP, study-based forms, templates, spreadsheet verification, and report amendments.
To archive QA-related records.
Involvement in NGCMA inspection procedure at the test facility.
To assist and carry out any duties assigned by Head Quality Assurance.
Desired Candidate Profile
Candidate with M.Pharma qualification and work experience of 2-5 years in the similar profile
