Job Description – Quality Assurance Unit (QAU)

Key Responsibilities
Maintain controlled copies of approved study plans, study plan amendments, and Standard Operating Procedures (SOPs) used within the test facility
Ensure access to the latest approved Master Schedule and maintain its availability for QA activities
Review study plans, amendments, and SOPs for compliance with Positive Laboratory Practice (GLP) principles and maintain documented records of the reviews
Review deviations, change controls, and associated documentation to ensure compliance with GLP requirements
Conduct routine reviews of logbooks, environmental monitoring records, and power backup system records to verify compliance and documentation accuracy
Perform study-based, facility-based, and process-based inspections to verify compliance with GLP principles and approved procedures
Verify that approved SOPs and study plans are available and being followed by study personnel during inspections




Assist in preparing and executing the Quality Assurance inspection and audit schedule
Maintain complete, accurate, and traceable records of all inspections, observations, and audit reports, and ensure their proper archival
Review final study reports to confirm that methods, procedures, observations, and results are accurately documented and are consistent with the corresponding raw data
Prepare the Quality Assurance Statement for review and approval, confirming inspections performed and GLP compliance, for inclusion with the final study report
Support internal and external GLP audits, regulatory inspections, and compliance initiatives by providing required documentation and records
Ensure that all QA activities are performed in accordance with applicable GLP guidelines, internal procedures, and regulatory requirements

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📌 QAU (Sonipat)
🏢 Crystal Crop Protection
📍 Sonipat