Key Responsibilities

- Analytical Testing

Perform routine analysis of raw materials, intermediates, APIs, finished products, and in-process samples.

Operate Analytical Instruments Such As

HPLC

GC

UV-Visible Spectrophotometer

FTIR

Karl Fischer

pH meter

Analytical balance

Other laboratory instruments as applicable

Perform testing according to approved specifications, analytical methods, and pharmacopoeial requirements.

Calculate, record, and review analytical results accurately.

- Sample Management

Receive and verify QC samples as per approved procedures.

Ensure proper sample identification, labeling, storage, and traceability.

Perform sample preparation according to approved methods.

Ensure testing is completed within established timelines.

- Documentation & Data Integrity

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

Follow Good Documentation Practices and ALCOA+ data-integrity principles.

Ensure raw data and analytical results are complete, accurate, attributable, and traceable.

Report documentation errors or data discrepancies 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.

- Instrument Management

Operate laboratory instruments according to approved SOPs.

Perform routine instrument checks and system suitability.

Maintain instrument usage and logbook records.

Report equipment breakdowns and abnormalities.

Support calibration, qualification, and preventive-maintenance activities.

- Reagents & Standards

Prepare reagents, solutions, mobile phases, and volumetric solutions as per approved procedures.

Ensure proper labeling and storage of reagents and solutions.

Maintain records for preparation, standardization, and expiry.





Monitor availability and expiry of reference standards and laboratory chemicals.

- Stability Testing

Perform testing of stability samples according to approved protocols and schedules.

Maintain stability sample and analytical records.

Report atypical or unexpected stability results promptly.

Support preparation and review of stability data.

- GMP / GLP Compliance

Follow GMP, GLP, SOPs, specifications, test methods, and safety procedures.

Maintain laboratory housekeeping and 5S.

Support internal, customer, and regulatory audits.

Participate in audit preparation and implementation of corrective actions.

- Safety & EHS

Follow laboratory safety procedures and chemical-handling requirements.

Wear appropriate PPE.

Handle solvents, reagents, compressed gases, and laboratory chemicals safely.

Follow laboratory waste-disposal procedures.

Report incidents, near misses, and unsafe conditions.

- Continuous Improvement

Participate in laboratory productivity and efficiency-improvement initiatives.

Support analytical method improvements and troubleshooting.

Participate in Kaizen, 5S, and other continuous-improvement activities.

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.

2–6 years of experience in API/pharmaceutical QC.

Valuable Hands-on Experience With HPLC And/or GC Is Preferred.

Key Skills

HPLC / GC analysis

UV / FTIR / KF

Wet chemistry

Analytical method execution

Sample preparation

OOS/OOT awareness

GMP / GLP

ALCOA+ and data integrity

Good Documentation Practices

Instrument handling

Laboratory safety

Analytical troubleshooting

Key KPIs

Timely completion of analytical testing

Accuracy of analytical results

Right-first-time testing

Documentation accuracy

OOS/OOT reporting and investigation support

Instrument utilization and compliance

Stability testing completion

GMP/GLP compliance

Data-integrity compliance

📌 Apprentice (Mumbai)
🏢 Cadila Pharmaceuticals
📍 Mumbai