Quality Controller

2 months ago

Baddi, India Job Provider Baddi Full time

In the pharmaceutical industry, the Quality Control (QC) department is responsible for ensuring that products meet the required quality standards and specifications. Here are the primary responsibilities of QC in pharmaceuticals:

- **Sampling and Testing**:

- Collect samples of raw materials, packaging materials, intermediates, and finished products according to approved sampling plans.
- Perform a range of physical, chemical, and microbiological tests on samples using validated analytical methods and instrumentation.
- **Method Development and Validation**:

- Develop and validate analytical methods for the identification, quantification, and characterization of drug substances and drug products.
- Validate methods to ensure they are accurate, precise, specific, robust, and reproducible.
- **Raw Material and Packaging Material Testing**:

- Test raw materials and packaging materials for identity, purity, potency, and compliance with specifications.
- Ensure that materials meet established quality standards before they are used in manufacturing processes.
- **In-process Testing**:

- Monitor and assess the quality of products at various stages of the manufacturing process (e.g., blending, granulation, compression) to ensure consistency and compliance with specifications.
- **Finished Product Testing**:

- Conduct comprehensive testing of finished pharmaceutical products to verify their identity, strength, purity, quality, and safety.
- Ensure that finished products meet regulatory requirements and release criteria before they are distributed to customers or released for sale.
- **Stability Testing**:

- Design and conduct stability studies to evaluate the long-term and accelerated stability of pharmaceutical products under different storage conditions.
- Monitor changes in product quality over time and determine shelf-life and storage recommendations based on stability data.
- **Data Analysis and Reporting**:

- Analyze test results and interpret data to assess product quality and compliance with specifications.
- Prepare accurate and comprehensive test reports documenting test methods, results, and conclusions for regulatory purposes.
- **Investigation of Out-of-Specification (OOS) Results**:

- Investigate deviations from specifications or unexpected test results (OOS, out-of-trend) to identify root causes and implement corrective and preventive actions (CAPAs) to prevent recurrence.
- **Documentation and Recordkeeping**:

- Maintain detailed records of all QC activities, including test procedures, equipment calibration, analytical data, and documentation of investigations and CAPAs.
- Ensure compliance with Good Documentation Practices (GDP) and regulatory requirements for recordkeeping.
- **Regulatory Compliance**:

- Ensure compliance with relevant regulations and guidelines, including Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and pharmacopeial standards (e.g., USP, EP).
- Support regulatory submissions by providing accurate and timely QC data and documentation

**Salary**: ₹15,000.00 - ₹40,000.00 per month

**Experience**:

- total work: 2 years (preferred)

Work Location: In person

**Speak with the employer**

+91 9805173600

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