5 - 10 years
3 - 6 Lacs
Posted:2 days ago|
Platform:
Work from Office
Full Time
Review system suitability parameters, and sample results to ensure precision and reliability. Identify and resolve discrepancies or deviations in data and ensure thorough documentation.
Ensure all analytical data and associated documentation meet GLP/GMP and regulatory requirements. Review and finalize method validation reports, investigation reports, and other critical documents.
Maintain accurate and comprehensive records of reviewed data and prepare summary reports for audits.
Ensure adherence to international regulatory standards (e.g.,ICH, FDA, and EMA) and internal SOPs.
Support regulatory audits and inspections by providing verified data and addressing reviewer queries.
Oversee data integrity compliance, ensuring properdocumentation and adherence to ALCOA+ principles.
Train and mentor junior reviewers and analysts on data review best practices, regulatory standards, and troubleshooting techniques.
Fusion Scientific Laboratories
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