Walk-in | Quality Control Analyst

Immacule Life Sciences; Solan; On-site; INR 400,000 - 600,000; Full time

Job summary

Immacule Life Sciences in Solan, Himachal Pradesh, seeks a QC professional to perform chemical and instrumental analysis of raw materials, in-process samples, finished products, and stability samples for injectable products.

You will operate HPLC, GC, UV-Vis, FTIR, pH meters, Karl Fischer, and dissolution equipment, ensure compliant testing per pharmacopoeial standards, and maintain documentation and records.

Qualifications

• Hands-on experience in pharmaceutical QC lab operations.
• Practical knowledge of HPLC and analytical instruments.
• Knowledge of GMP, GLP, OOS/OOT, deviation, CAPA, and data integrity.
• Good documentation and communication skills.

Responsibilities

• Perform chemical and instrumental analysis of raw materials, in-process samples, finished products, and stability samples.
• Test injectable products per approved specifications, STPs, and pharmacopoeial requirements.
• Operate instruments such as HPLC, GC, UV-Vis, FTIR, pH meters, Karl Fischer, and dissolution apparatus.
• Perform assays and related tests for injectables including impurities, pH, water content, and other quality attributes.
• Ensure proper sampling, testing, documentation, and timely release of analytical results.
• Prepare and maintain analytical worksheets, raw data, test reports, and QC records.
• Follow GLP, GMP, ALCOA+ data integrity and safety requirements.
• Investigate OOS/OOT and laboratory deviations per procedures.
• Support method validation, verification, transfer, development, and instrument qualification.
• Maintain instrument calibration and routine maintenance as per SOPs.
• Coordinate with QA, Production, Microbiology and other departments for timely testing and investigations.

Skills

QC operations

HPLC

Documentation

Shift work

GMP/GLP

Tools

HPLC

GC

UV-Vis

FTIR

pH Meter

Karl Fischer

Dissolution Apparatus

Analytical balances

Job description

Role & responsibilities

• Perform chemical and instrumental analysis of raw materials, in-process samples, finished products, and stability samples.
• Conduct testing of injectable products as per approved specifications, STPs, and pharmacopoeial requirements.
• Handle instruments such as HPLC, GC, UV-Visible Spectrophotometer, FTIR, pH Meter, Karl Fischer, Dissolution Apparatus, and analytical balances as applicable.
• Perform assay, related substances/impurities, identification, pH, water content, particulate matter, clarity, and other applicable tests for injectable products.
• Ensure proper sampling, testing, documentation, and timely release of analytical results.
• Prepare and maintain analytical worksheets, raw data, test reports, logbooks, and other QC records.
• Follow GLP, GMP, data integrity (ALCOA+) and laboratory safety requirements.
• Investigate and report Out of Specification (OOS), Out of Trend (OOT), and laboratory incidents/deviations as per procedures.
• Support method validation, method verification, method transfer, analytical method development, and instrument qualification activities.
• Perform calibration, verification, and routine maintenance of QC laboratory instruments as per SOPs.
• Maintain proper laboratory housekeeping and ensure availability of chemicals, reagents, standards, and consumables.
• Support stability study testing and maintain stability-related documentation.
• Coordinate with QA, Production, Microbiology, and other cross-functional departments for timely completion of testing and investigations.
• Participate in internal audits, regulatory inspections, and customer audits as required.
• Ensure compliance with current IP, BP, USP, Ph. Eur. and other applicable pharmacopoeial requirements.
• Follow all applicable company SOPs, safety procedures, and EHS requirements.

Preferred candidate profile

• Hands-on experience in pharmaceutical QC laboratory operations, preferably injectable manufacturing.
• Practical knowledge of HPLC and other analytical instruments.
• Knowledge of GMP, GLP, OOS/OOT, deviation, CAPA, change control, and data integrity.
• Good understanding of pharmacopoeial testing and analytical procedures.
• Good documentation and communication skills.
• Ability to work independently as well as in a team.
• Willingness to work in shift operations, if required.