Quality Control Reviewer

5 days ago


Hingna Nagpur Maharashtra, India Nitika Pharmaceuticals Full time

A quality control (QC) reviewer in the pharmaceutical industry reviews data and documentation to ensure it meets quality standards and regulatory guidelines:

- **Data review**: Reviews raw material, release, and in-process testing data to ensure it complies with guidelines like cGMPs, GDP, FDA, EMA, and ICH
- **Documentation review**: Reviews laboratory raw data, procedures, and reports to ensure they meet GMP standards
- **Audit trail review**: Reviews analytical instrumentation audit trails to ensure data integrity
- **Raw data notebook review**: Reviews raw data notebooks for documented information like calculation verification, standard preparation, and instrument calibration
- **Trend analysis**: Performs trend analysis for laboratory test results
- **Standard operating procedure (SOP) creation**: Creates or updates SOPs as required

QC reviewers in the pharmaceutical industry may also:

- Assist in writing and reviewing QA events, deviations, and investigations
- Interact with QC analysts, group leaders, and managers of other departments
- Assist in the audit of QC laboratories
- Educate analytical chemists to improve data reporting

**Job Type**: Permanent

Pay: ₹20,000.00 - ₹25,000.00 per month

**Experience**:

- total work: 4 years (required)

Work Location: In person



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