Officer

Cadila Pharmaceuticals Limited; Mumbai City; Vor Ort; INR 300.000 - 420.000; Vollzeit

Zusammenfassung

Cadila Pharmaceuticals Limited in Mumbai seeks a Quality Control Analyst to perform and document analytical testing of raw materials, intermediates, APIs and finished products in line with approved specifications and GMP standards.

The role requires hands-on work with HPLC, GC, UV-Vis, FTIR, Karl Fischer and pH meters, including method validation support and investigations. B.Sc./M.Sc. in chemistry or equivalent is preferred; 1–4 years’ API QC experience is desirable.

Qualifikationen

• Bachelor's/Master's degree in chemistry or pharmacy-related field is required.
• Relevant API/pharmaceutical QC experience preferred (1–4 years).
• Hands-on experience with HPLC/GC and analytical methods is desired.

Aufgaben

• Perform routine analysis of raw materials, intermediates, APIs and finished products.
• Operate analytical instruments such as HPLC, GC, UV-Vis, FTIR, Karl Fischer and pH meter.
• Prepare mobile phases, diluents, reagents, standards, and samples.
• Perform system suitability tests and ensure results meet acceptance criteria.
• Review chromatograms, calculations, and raw data for accuracy.
• Assist in method validation, verification, transfer and stability testing.
• Support OOS/OOT investigations and laboratory compliance activities.
• Coordinate with QA, production and other departments for timely testing.

Ausbildung

B.Sc./M.Sc. Chemistry, B.Pharm/M.Pharm or equivalent qualification

Tools

HPLC

GC

UV-Vis Spectrophotometer

FTIR

Karl Fischer

pH Meter

Jobbeschreibung

Job Purpose

To perform and document analytical testing of raw materials, intermediates, APIs, in-process and finished products in accordance with approved specifications, analytical methods, SOPs, GMP and data-integrity requirements.

Key Responsibilities

• Perform routine analysis of raw materials, intermediates, APIs, finished products and stability samples.


• Operate and handle analytical instruments such as HPLC, GC, UV-Visible Spectrophotometer, FTIR, Karl Fischer, pH meter and other laboratory equipment.


• Perform testing for assay, related substances, impurities, residual solvents, water content, identification and other specified quality parameters.


• Prepare mobile phases, diluents, reagents, standard and sample solutions accurately.


• Perform system suitability tests and ensure analytical results meet established acceptance criteria.


• Review chromatograms, calculations, raw data and analytical worksheets for completeness and accuracy.


• Carry out routine troubleshooting of HPLC and GC and coordinate with seniors/vendors for major instrument issues.


• Perform sampling and analysis as per approved sampling plans and specifications.


• Support OOS, OOT, deviation and analytical investigation activities.


• Assist in method validation, method verification, method transfer and analytical method development activities.


• Perform stability testing as per approved stability protocols and schedules.


• Maintain instrument logbooks, calibration records, analytical worksheets and laboratory records.


• Ensure proper calibration and preventive maintenance of QC instruments.


• Follow GMP, GLP, SOPs and ALCOA+ data-integrity principles.


• Maintain proper housekeeping and ensure safe handling and disposal of chemicals and laboratory waste.


• Coordinate with QA, Production and other departments for timely completion of testing.


• Participate in internal audits, regulatory inspections and laboratory compliance activities when required.

Qualification

B.Sc./M.Sc. Chemistry, B.Pharm/M.Pharm or equivalent qualification. Relevant experience in pharmaceutical/API quality control preferred.

Experience

Experience 1-4 years of relevant experience in API / pharmaceutical QC, preferably with hands-on HPLC and GC experience.