Senior Officer

Cadila Pharmaceuticals Limited; Dahej; On-site; INR 500,000 - 800,000; Full time

Job summary

Cadila Pharmaceuticals Limited in India seeks a QC Analyst to perform chemical and instrumental analysis per approved specifications. The role involves operating HPLC and GC systems, reviewing chromatograms, ensuring data integrity, and supporting method validation and investigations.

You will collaborate with QA, Production, and R&D to resolve quality-related issues, while guiding junior staff. The candidate will maintain documentation, ensure compliance with cGMP/GLP, and participate in audits

Qualifications

• Experience in HPLC/GC method analysis
• Knowledge of GMP/GLP and data-integrity principles
• Understanding of OOS/OOT, deviation, CAPA and change-control processes
• Experience with LIMS and electronic analytical data systems preferred
• Ability to review chromatograms, calculations and analytical results

Responsibilities

• Perform chemical and instrumental analysis per approved specs and methods
• Operate and troubleshoot analytical instruments (HPLC, GC/GC-HS, UV-Vis, FTIR, Karl Fischer, Auto Titrator)
• Prepare reagents, standard solutions, test solutions per SOP
• Review analytical data, chromatograms, calculations and lab records for accuracy
• Ensure proper handling and storage of reference standards and reagents
• Calibrate instruments and ensure preventive maintenance
• Conduct stability sample analysis per protocol and schedule
• Support method validation, verification, and transfers
• Initiate investigations related to OOS/OOT, deviations
• Participate in CAPA and QMS activities
• Maintain QC documentation and LIMS records
• Prepare and review SOPs and analytical protocols
• Ensure compliance with cGMP, GLP, data integrity and EHS
• Support audits with analytical records
• Coordinate with QA, Production, R&D and others
• Guide junior analysts/chemists
• Maintain laboratory housekeeping and waste-disposal practices
• Ensure QC activities are performed within timelines

Skills

HPLC

GC

API analysis

OOS/OOT

CAPA

GMP/GLP

Data integrity

LIMS

Troubleshooting

Tools

HPLC systems

GC instruments

UV-Vis

FTIR

Karl Fischer

Auto Titrator

Job description

• Perform chemical and instrumental analysis of raw materials, intermediates, in-process samples and APIs as per approved specifications and analytical methods.
• Operate and troubleshoot analytical instruments including HPLC, GC/GC-HS, UV-Visible, FTIR, Karl Fischer, Auto Titrator and other QC laboratory instruments.
• Perform testing as per IP, BP, USP, EP and approved in-house/customer specifications.
• Prepare reagents, standard solutions, volumetric solutions and test solutions as per SOP.
• Review analytical data, chromatograms, calculations, worksheets and laboratory records for accuracy and completeness.
• Ensure proper handling, storage and reconciliation of reference standards, working standards, impurities, chemicals and laboratory reagents.
• Perform instrument calibration and ensure timely qualification, preventive maintenance and troubleshooting.
• Conduct stability sample analysis and ensure testing is completed as per the approved stability protocol and schedule.
• Support analytical method validation, method verification, method transfer and analytical procedure-related activities.
• Initiate and/or support investigations related to OOS, OOT, laboratory incidents, deviations and atypical results.
• Participate in preparation and implementation of CAPA, change controls and other QMS activities.
• Review HPLC/GC audit trails and ensure compliance with applicable data-integrity requirements, including electronic records and electronic signatures.
• Maintain QC documentation, logbooks, analytical reports, COAs and LIMS records.
• Prepare and review SOPs, specifications, test methods and analytical protocols when required.
• Ensure compliance with cGMP, GLP, data integrity and EHS requirements.
• Support internal, customer and regulatory audits by providing analytical records and required information.
• Coordinate with QA, Production, R&D, Engineering, Warehouse and other departments for timely resolution of quality-related issues.
• Guide junior QC analysts/chemists and provide technical support in day-to-day laboratory activities.
• Maintain laboratory housekeeping, chemical inventory, glassware and waste-disposal practices.
• Ensure all QC activities are performed accurately and within defined timelines.

Required Technical Skills

• Strong hands-on experience in HPLC and GC.
• Good knowledge of API analytical testing and pharmacopoeial requirements.
• Understanding of OOS/OOT, deviation, CAPA and change-control processes.
• Knowledge of GMP, GLP and data-integrity principles.
• Experience with LIMS and electronic analytical data systems is preferred.
• Good analytical troubleshooting and investigation skills.
• Ability to review chromatograms, calculations and analytical results.