Reasearch Associate

Indoco Remedies; Navi Mumbai; On-site; INR 600,000 - 1,200,000; Full time

Job summary

Indoco Remedies is seeking an Analytical Chemist to operate, maintain, and troubleshoot advanced analytical instruments in a GMP/GLP environment. You will lead Analytical Method Development (AMD) and validation for assay, dissolution, and nitrosamine testing, supporting drug substance and product development.

You will perform QC/QA analyses for In-Process, Finished Goods, Raw Materials, and Packaging Materials, and maintain compliance with USP/IP/BP/EP using LabSolutions, Empower, Chromeleon,

Qualifications

• Operate, maintain, and troubleshoot analytical instruments in a GMP/GLP environment.
• Lead Analytical Method Development (AMD) and validation for assay, dissolution, and nitrosamine testing.
• Identify unknown mass peaks using LC-MS/MS to support drug substance/product development.

Responsibilities

• Conduct quantitative and qualitative analysis for In-Process, Finished Goods, Raw Materials, and Packaging Materials.
• Prepare STP, OBS, SOPs, and audit trail records.
• Regular calibration and maintenance of KF, pH meters, balances, GC, and HPLC.
• Ensure compliance with cGMP/GLP and pharmaceutical standards (USP/IP/BP/EP).
• Utilize chromatography data software (LabSolutions, Empower, Chromeleon, Clarity, Iris-32).
• Perform stability testing and R&D sample analysis for OSD products, capsules, tablets, and nutraceuticals.

Skills

Analytical instruments

AMD Validation

LC-MS/MS

HPLC/UPLC

GMP/GLP

Chromatography software

Tools

LabSolutions

Empower

Chromeleon 7.2

Clarity

Iris-32

Job description

Role & responsibilities

• Operate, maintain, and troubleshoot advanced analytical instruments including:
  • LC-MS/MS: Sciex QTRAP 4500, Waters Xevo TQ-XS
  • UPLC & HPLC: Waters Acquity, Shimadzu (LC2010, LC2030 with UV & PDA)
  • Gas Chromatography: Agilent 8890, Thermo Fisher TRACE 1110, Shimadzu Nexis GC-2030 (Autosampler & Headspace)
  • Spectroscopy & Testing: UV-Vis, FTIR, Dissolution Testers (Electro lab / Lab-India), Karl Fischer (KF), and Titration.
• Lead Analytical Method Development (AMD) and validation for assay, dissolution, and nitrosamine impurity testing (e.g., N-Nitrosamines).
• Identify unknown mass peaks using LC-MS/MS techniques to support drug substance and drug product development.

2. Quality Control & Quality Assurance

• Conduct quantitative and qualitative analysis for In-Process, Finished Goods (FG), Raw Materials (RM), and Packaging Materials (PM).
• Prepare Standard Testing Procedures (STP), Operational Specification Sheets (OBS), SOPs, and audit trail records.
• Perform regular calibration and routine maintenance of laboratory instruments (KF, pH meters, balances, GC, HPLC).

3. Compliance & Documentation

• Work in strict compliance with cGMP, GLP, and international pharmacopeia standards (USP, IP, BP, EP).
• Proficiently use chromatography data software (LabSolutions, Empower, Chromeleon 7.2, Clarity, Iris-32).
• Perform stability testing and regular R&D sample analysis for OSD products, capsules, tablets, pellets, and nutraceuticals.