Senior Officer

Contract Pharmaceuticals Limited; Mumbai City; Presencial; INR 420.000 - 660.000; Jornada completa

Descripción de la vacante

Contract Pharmaceuticals Limited in Mumbai is seeking a QA/QC Analyst to perform routine analyses across materials and products, operating HPLC, GC, UV-Vis, FTIR, Karl Fischer, and pH meters. You will ensure data integrity and GMP/GLP compliance, and prepare various solutions and samples for testing.

You will review chromatograms, assist in OOS/OOT investigations, and support method validation and stability protocols.

Formación

• Qualification: B.Sc./M.Sc. Chemistry, B.Pharm/M.Pharm or equivalent qualification.
• Relevant experience in pharmaceutical/API quality control preferred.
• Experience 1-4 years in API/pharmaceutical QC with hands-on HPLC and GC.

Responsabilidades

• Perform routine analysis of raw materials, intermediates, APIs, finished products and stability samples.
• Operate analytical instruments such as HPLC, GC, UV-Visible Spectrophotometer, FTIR, Karl Fischer, pH meter and other lab equipment.
• Prepare mobile phases, diluents, reagents, standard and sample solutions accurately.
• Review chromatograms, calculations, raw data and analytical worksheets for completeness and accuracy.
• Carry out troubleshooting of HPLC and GC and coordinate with seniors/vendors for instrument issues.
• Support OOS, OOT, deviation and analytical investigation activities.

Conocimientos

HPLC

GC

UV-Vis

FTIR

Karl Fischer

pH meter

Educación

B.Sc./M.Sc. Chemistry

B.Pharm/M.Pharm

Herramientas

HPLC

GC

UV-Vis Spectrophotometer

FTIR

Karl Fischer

pH meter

Descripción del empleo

Job Description:

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.

Requirements:

QualificationB.Sc./M.Sc. Chemistry, B.Pharm/M.Pharm or equivalent qualification.Relevant experience in pharmaceutical/API quality control preferred.Experience1-4 years of relevant experience in API / pharmaceutical QC, preferably with hands-on HPLC and GC experience.