About this role
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.
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 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.
6. 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.
8. 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.
9. 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
Good 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