06 Sep
|
Dr. Reddy's Laboratories
|
Baddi
06 Sep
Dr. Reddy's Laboratories
Baddi
Job Description
Job Summary
Competent and detail-oriented QC Analyst to support Quality Control activities for Oral Solid Dosage (OSD) formulations. The incumbent will be responsible for sampling, testing, and release of Raw Materials (RM) and Packing Materials (PM) and Finished Product (FP) in accordance with approved specifications, cGMP requirements, and internal quality standards. The role requires hands-on expertise in analytical instrumentation, laboratory documentation, data integrity practices, and adherence to regulatory requirements.
Key Responsibilities
Analytical Testing
Perform sampling and analysis of Raw Materials and Packing Materials as per approved specifications, STPs, and pharmacopoeial requirements.
Execute routine quality control testing and ensure timely reporting of results.
Prepare and review analytical records, worksheets, and test reports.
Instrument Operation & Maintenance
Operate, maintain, and troubleshoot analytical instruments, including:
HPLC (High-Performance Liquid Chromatography)
GC (Gas Chromatography)
Auto Titrator
Karl Fischer Titrator
UV-Visible Spectrophotometer
FTIR Spectrophotometer
Ensure proper use, cleaning, and upkeep of laboratory equipment as per approved SOPs.
Perform instrument calibration, verification, and routine maintenance activities as per schedule.
Documentation & Compliance
Maintain accurate and complete analytical records in compliance with cGMP, GLP, and ALCOA+ data integrity principles.
Ensure proper documentation, logbook entries, laboratory registers, and traceability of all activities.
Maintain compliance with SOPs, STPs, specifications, and applicable regulatory requirements.
Perform SAP transactions related to sample tracking, result entry, and documentation management.
Investigation & Quality Systems
Support investigations related to OOS (Out of Specification), OOT (Out of Trend), deviations, and laboratory incidents.
Report discrepancies, abnormal observations, and incidents promptly to the Group L
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