The candidate will be responsible for reviewing analytical data and ensuring that all laboratory activities comply with approved procedures, regulatory guidelines, and data integrity requirements. The role involves thorough evaluation of test results, documentation, and instrument records to support accurate, reliable, and timely release of analytical reports.
Roles & Responsibilities
Review analytical raw data, chromatograms, worksheets, and test reports for accuracy, completeness, and compliance.
Ensure all laboratory tests (assay, dissolution, content uniformity, stability, etc.) are performed and documented as per approved procedures.
Verify calibration and qualification status of analytical instruments before use.
Review instrument logbooks, usage records, and audit trail data for completeness and correctness.
Check calculations, sample details, and batch information for accuracy.
Ensure timely review and release of analytical reports to meet project and production timelines.
Identify, document, and escalate data discrepancies, deviations, or non-conformances to the QC Manager.
Support investigations related to out-of-specification (OOS), out-of-trend (OOT), or atypical results.
Ensure compliance with SOPs, specifications, regulatory requirements, and data integrity standards.
Participate in internal and external audits by providing required documentation and support.
* Contribute to continuous improvement initiatives within the Quality Control department.
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