About this role
Key Responsibilities
1. 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.
2. 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.
3. 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.
4. 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 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.
6. 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.
7. 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.
8. 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.
9. 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.
10. 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.
Good 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