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Analytical Testing

Perform routine analysis of raw materials, intermediates, APIs, and in-process samples. Carry out testing using applicable analytical techniques such as: HPLC GC UV-Visible Spectrophotometer FTIR Karl Fischer pH Titration / wet chemistry Moisture / LOD Follow approved analytical methods, specifications, and pharmacopoeial requirements. Perform calculations and report analytical results accurately. 2.

Sample

Handling

Receive and verify samples according to approved procedures. Ensure proper sample identification, labeling, storage, and traceability. Perform sample preparation as per approved methods. Complete assigned testing within established timelines. 3.

Laboratory

Documentation

Maintain laboratory notebooks, worksheets, logbooks, chromatograms, and analytical records.

Follow Good Documentation

Practices. Record analytical observations and results accurately and contemporaneously. Follow ALCOA+ data-integrity principles. Report errors, discrepancies, or abnormal observations immediately.

- OOS / OOT / Deviation Support

Immediately report OOS, OOT, atypical results, instrument failures, and laboratory incidents. Support laboratory investigations and Root Cause Analysis. Provide required raw data and technical information for investigations. Support implementation of CAPA and corrective actions. 5.

Instrument

Operation

Operate HPLC, GC, UV, FTIR, KF, balances, and other laboratory instruments as authorized. Perform system suitability and routine instrument checks. Maintain instrument usage and logbook records. Report instrument abnormalities and breakdowns. Support calibration, qualification, and preventive-maintenance activities.

- Reagents & Standards

Prepare reagents, solutions, mobile phases, and volumetric solutions according to approved procedures. Ensure proper labeling, storage, and expiry monitoring.



Maintain preparation and standardization records. Monitor availability of reference standards and laboratory chemicals. 7.

Stability

Testing

Perform analysis of stability samples according to approved protocols and schedules. Maintain stability testing records. Report atypical or unexpected stability results immediately. Support stability data compilation and trending.

- GMP / GLP Compliance

Follow GMP, GLP, SOPs, specifications, analytical methods, and laboratory procedures. Maintain laboratory cleanliness and 5S. Support internal, customer, and regulatory audits. Ensure compliance with data-integrity and documentation requirements.

- Safety & EHS

Follow laboratory safety procedures and chemical-handling requirements. Wear appropriate PPE. Handle solvents, reagents, compressed gases, and laboratory chemicals safely. Follow approved laboratory waste-disposal procedures. Report incidents, near misses, spills, and unsafe conditions. 10.

Continuous

Improvement

Participate in QC laboratory improvement initiatives. Support analytical troubleshooting and method improvements. Participate in Kaizen, 5S, and laboratory productivity initiatives. Suggest improvements to laboratory processes and documentation. Qualifications

M.Sc. in Chemistry / Analytical Chemistry / Pharmaceutical Chemistry preferred. B.Sc./B.Pharm with relevant QC experience may be considered. 1–4 years of experience in API/pharmaceutical QC. Hands-on experience with HPLC and/or GC preferred. Key Skills

HPLC / GC UV / FTIR / KF Wet chemistry Analytical testing Sample preparation OOS/OOT awareness GMP / GLP ALCOA+ and data integrity Valuable Documentation Practices Laboratory safety Instrument handling Analytical troubleshooting Key KPIs

Timely completion of QC testing Analytical accuracy Right-first-time testing Documentation accuracy OOS/OOT reporting and investigation support

📌 Officer (Ankleshwar)
🏢 DigiCAD
📍 Ankleshwar