Senior Executive

To perform and supervise analytical testing of raw materials, intermediates, finished API products and stability samples, ensuring compliance with approved specifications, cGMP requirements and regulatory standards. The incumbent will be responsible for laboratory operations, analytical instrument handling, documentation, data integrity and timely release of analytical results.
2. Key Roles & Responsibilities
A. Analytical Testing & Laboratory Operations
- Perform analysis of raw materials, intermediates, in-process samples and finished API products.
- Conduct analytical testing as per approved specifications, STPs and analytical methods.
- Handle routine and advanced analytical testing using HPLC, GC, UV, FTIR and other laboratory instruments.
- Perform wet chemistry analysis, titrations, loss on drying, water content and related chemical tests.
- Ensure timely testing and reporting of samples to support production activities.
- Review analytical observations and ensure accuracy of test results.
B. Instrument Handling & Calibration
- Independently operate and troubleshoot analytical instruments such as:
- HPLC (High Performance Liquid Chromatography)
- GC (Gas Chromatography)
- UV-Visible Spectrophotometer
- FTIR
- Karl Fischer Apparatus
- pH Meter
- Analytical Balance
- Melting Point Apparatus
- Ensure proper instrument calibration, qualification and preventive maintenance.
- Maintain instrument usage logbooks and calibration records.
- Coordinate with instrument vendors for troubleshooting and technical support.
- Ensure instruments are maintained in a qualified and calibrated state.
C. In-Process & Finished Product Analysis
- Perform testing of in-process samples received from API production blocks.
- Analyze finished API products as per approved analytical specifications.
- Conduct testing of solvents, raw materials and intermediates.
- Ensure compliance with analytical specifications and acceptance criteria.
- Coordinate with Production and QA for timely sample testing and result communication.
- Support batch release activities through timely and accurate analytical reporting.
D. Stability Studies
- Perform stability sample analysis as per approved stability protocols.
- Ensure sample storage and testing as per defined stability conditions.
- Maintain stability study records and analytical reports.
- Monitor stability trends and report any abnormal analytical observations.
- Support stability study documentation and periodic reviews.
E. OOS / OOT Investigation
- Participate in Out of Specification (OOS) and Out of Trend (OOT) investigations.
- Perform preliminary laboratory investigations for analytical failures.
- Review chromatograms, calculations, instrument conditions and analytical procedures.
- Ensure proper documentation of laboratory investigations.
- Support root cause analysis and implementation of CAPA.
- Ensure compliance with approved investigation procedures.
F. GMP & Documentation Compliance
- Follow cGMP, GLP and Good Documentation Practices.
- Maintain analytical worksheets, laboratory notebooks and instrument logbooks.
- Ensure accurate recording and reporting of analytical results.
- Follow approved SOPs, STPs and testing procedures.
- Maintain proper control of reference standards, working standards and reagents.
- Ensure laboratory readiness for internal, customer and regulatory audits.
G. Data Integrity & Laboratory Compliance
- Ensure adherence to ALCOA+ principles in all laboratory activities.
- Maintain data integrity in analytical instruments and computerized systems.
- Review chromatograms, audit trails and electronic analytical records as applicable.
- Ensure proper handling and storage of electronic and hard-copy data.
- Prevent unauthorized changes, manipulation or deletion of analytical data.
- Follow laboratory access control and data backup procedures.
H. Laboratory Management & Coordination
- Ensure proper housekeeping and safety within the QC laboratory.
- Maintain adequate availability of chemicals, solvents, reagents and consumables.
- Coordinate with QA, Production and Warehouse for sample testing priorities.
- Support method validation, method verification and method transfer activities.
- Assist in training junior QC personnel on analytical techniques and SOPs.
- Ensure timely completion of assigned laboratory activities.