Quality Control

Hetero; Solan; On-site; INR 600,000 - 900,000; Full time

Job summary

Hetero in Solan, Himachal Pradesh, seeks an experienced analytical chemist to perform comprehensive analysis across materials and products. You will operate HPLC/UPLC/GC, UV-Vis, FTIR, and Karl Fischer, ensuring data integrity and compliance with cGMP.

Responsibilities include method verification, transfer, validation, OOS/OOT investigations, and preparation of reports and SOPs, with participation in regulatory audits by USFDA/EU-GMP and other agencies.

Qualifications

• Experience analyzing Raw Materials, In-Process, Finished Products, Stability Samples, and Packaging Materials.
• Experience with regulatory guidelines, audits, and data integrity requirements.
• Proficiency in method verification, method transfer, and analytical method validation; investigations of OOS/OOT.

Responsibilities

• Perform analysis of Raw Materials, In-Process, Finished Products, Stability Samples, and Packaging Materials.
• Operate and troubleshoot analytical instruments like HPLC, UPLC, GC, UV-Vis, Dissolution, FTIR, and Karl Fischer.
• Conduct method verification, transfer, and analytical method validation.

Skills

HPLC

UPLC

GC

Dissolution

UV-Visible Spectrophotometer

FTIR

Karl Fischer

Data Integrity

cGMP

Tools

HPLC

UPLC

GC

UV-Visible Spectrophotometer

Dissolution Apparatus

FTIR

Karl Fischer

Job description

Role & responsibilities

• Perform analysis of Raw Materials, In-Process, Finished Products, Stability Samples, and Packaging Materials.
• Operate and troubleshoot analytical instruments such as HPLC, UPLC, GC, UV-Visible Spectrophotometer, Dissolution Apparatus, FTIR, and Karl Fischer.
• Conduct method verification, method transfer, and analytical method validation activities.
• Ensure compliance with cGMP, GLP, GDP, Data Integrity, and Regulatory Guidelines.
• Review analytical data, laboratory notebooks, and reports.
• Investigate OOS (Out of Specification), OOT (Out of Trend), deviations, and laboratory incidents.
• Preparation and review of SOPs, STPs, specifications, and analytical reports.
• Support regulatory audits including USFDA, MHRA, EU-GMP, WHO, TGA, and ANVISA inspections.
• Ensure calibration, maintenance, and qualification of laboratory instruments.
• Participate in stability studies and trend analysis activities.

Preferred candidate profile

Hands-on experience in HPLC, UPLC, GC, Dissolution, UV-Visible Spectrophotometer, FTIR, Karl Fischer, and Wet Analys