Quality Control

2 days ago

Pithampur, India Makin Laboratories Pvt.Ltd. Full time

**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.

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

Work Location: In person

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