Dr.Reddy’s Laboratories Ltd Hiring for Team Member – Quality Control

Team Member – Quality Control (In-Process)

Job Summary

The role of Team Member – Quality Control (QC) involves performing routine analytical testing of raw materials, intermediates, in-process samples, and finished products (API) in compliance with GMP, GLP, and GDP requirements. The position is responsible for operating and calibrating laboratory instruments (such as HPLC and other analytical equipment), ensuring adherence to approved specifications, test procedures (STP), and methods of analysis (MOA).

The role includes maintaining laboratory standards such as proper documentation, data integrity, housekeeping, and safety practices during chemical handling. The individual ensures readiness of instruments, reagents, and materials prior to analysis, including verification of calibration status, validity of chemicals, and preparation of solutions.

Additionally, the job involves recording and reporting analytical results, including handling deviations such as OOS (Out of Specification) and OOT (Out of Trend), supporting method verification/transfer activities, maintaining records, and coordinating through systems like MES for sample release and tracking.

The role also requires participation in training programs, analyst qualification, instrument maintenance coordination, and ensuring smooth shift handovers, with any additional responsibilities as assigned by supervisors.

Roles & Responsibilities

• Ensure compliance with GMP, GLP, and GDP
• Follow QC laboratory entry and exit procedures.
• Perform analysis of raw materials, intermediates, in-process samples, APIs, stability samples, and working standards.
• Operate analytical instruments (HPLC, etc.) as per approved SOPs.
• Ensure instrument calibration before analysis and perform periodic calibration.
• Verify SPEC and MOA parameters prior to analysis.
• Prepare mobile phase, reagents, and solutions as per procedures.
• Check validity of chemicals, reagents, solvents, and standards before use.
• Use cleaned and dried glassware for all analyses.
• Ensure proper column selection, conditioning, and washing procedures.
• Monitor Milli-Q water quality (resistivity) before use.
• Follow injection sequence as per STP before analysis.
• Record and maintain analytical raw data and documentation accurately.
• Ensure chromatograms are clear and legible.
• Store test solutions until batch release.
• Report OOS, OOT results, and incidents immediately.
• Perform method transfer and method verification studies.
• Release in-process samples through MES system.
• Maintain inward registers and closing records.
• Raise work orders and breakdown requests for laboratory maintenance.
• Maintain records such as HPLC lamp hours usage.
• Ensure good housekeeping in the laboratory.
• Follow safety precautions while handling chemicals and solvents
• Complete assigned LMS trainings and analyst qualification.
• Ensure proper shift handover..
• Perform additional tasks assigned by HOD/designee.

Educational qualification: An M.Sc. degree in Chemistry

Minimum work experience: 2 to 6 years

Skills & attributes:

Technical Skills

HPLC

GC

Empower data processing

Wet analysis

Behavioural skills

• Attention to detail and commitment to ensuring compliance with QMS (Quality Management System) documents, including OOS (Out-of-Specification), OOT (Out-of-Trend), and Incident investigations.
• Ability to respond to internal and external audits and participate in other QMS-related activities.
• Strong organizational skills for LIMS (Lab Information Management System) related activities.
• Effective communication and collaboration skills for coordinating and implementing of SOPs.

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