Quality control (stability , Raw Material , HLPC)

Raw Material QC (Quality Control) Role Purpose:

To ensure all raw materials received are tested, verified, and released as per pharmacopoeia and internal quality standards.

Key Responsibilities:

• Sampling and analysis of raw materials (API, excipients, solvents, etc.) as per SOPs.
• Perform identification, assay, and other tests using wet chemistry and instrumental methods.
• Maintain and update raw material logbooks and records.
• Ensure compliance with pharmacopeial standards (IP, BP, USP, EP).
• Preparation of standard test solutions and reagents.
• Report out-of-specification (OOS) or deviations immediately.

2. Stability Section QC Role Purpose:

To monitor and analyze the stability of finished products and intermediates under various storage conditions to ensure product quality over its shelf life.

Key Responsibilities:

• Set up and maintain stability chambers as per ICH guidelines.
• Sampling of products at scheduled intervals (accelerated & long-term stability studies).
• Perform testing of stability samples (assay, dissolution, degradation products, physical parameters).
• Prepare stability study protocols and reports.
• Trend analysis of stability data and reporting abnormalities.
• Coordinate with QA and Regulatory Affairs for stability study data submission.
• Ensure compliance with cGMP and ICH Q1 guidelines

HPLC Analyst (QC) Role Purpose:

To perform analytical testing of raw materials, intermediates, and finished products using HPLC to ensure compliance with specifications.

Key Responsibilities:

• Perform analysis of raw materials, in-process, finished products, and stability samples using HPLC.
• Method validation, calibration, and routine maintenance of HPLC instruments.
• Preparation of mobile phases, standards, and sample solutions.
• Troubleshooting HPLC issues and maintaining instrument logbooks.
• Document results in raw data sheets and LIMS as per ALCOA+ principles.
• Ensure compliance with pharmacopeial methods or validated methods.

Job Type: Full-time

Pay: ₹18,000.00 - ₹25,000.00 per month

Work Location: In person