- Location
- Sonipat, Haryana, India
- Job type
- Full-time
About the role
Crystal Crop Protection Limited
Website:
crystalcropprotection.com
Job details:
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 Good 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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