Junior Officer

Cadila Pharmaceuticals Limited; Dahej; On-site; INR 350,000 - 550,000; Full time

Job summary

Cadila Pharmaceuticals Limited in Dahej, India seeks a QC Analyst to perform chemical and instrumental analysis of raw materials, intermediates, in-process samples and APIs according to approved specs. You will operate HPLC, GC, UV-Vis, and other QC instruments, review data, maintain records, and ensure compliance with GMP/GLP and data-integrity standards.

Responsibilities include instrument calibration, stability testing, method validation support, CAPA participation, and investigations related

Qualifications

• Hands-on experience with analytical instruments (HPLC/GC).
• Understanding of pharmacopoeial requirements for API testing.
• Knowledge of OOS/OOT, deviation, CAPA and change-control processes.
• Familiarity with GMP/GLP and data-integrity principles.

Responsibilities

• Perform chemical and instrumental analysis of raw materials, intermediates, in-process samples and APIs per specifications and methods.
• Operate and troubleshoot analytical instruments including HPLC, GC/GC-HS, UV-Visible, FTIR, Karl Fischer, Auto Titrator and other QC lab instruments.
• Test as per IP, BP, USP, EP and approved in-house/customer specs.
• Prepare reagents, standard solutions and test solutions per SOP.
• Review analytical data, chromatograms, calculations and lab records for accuracy and completeness.
• Ensure proper handling, storage and reconciliation of reference standards, working standards and reagents.
• Perform instrument calibration and ensure timely qualification and maintenance.
• Conduct stability sample analysis per approved stability protocol and schedule.
• Support analytical method validation, verification, transfer and related activities.
• Initiate and/or support investigations related to OOS, OOT, incidents, deviations and atypical results.
• Participate in CAPA, change controls and other QMS activities.
• Review audit trails and ensure data integrity compliance.

Skills

HPLC

GC

API testing

Data integrity

Tools

LIMS

Electronic data systems

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.