Amneal Pharmaceuticals
Website:
amneal.com
Job details:
Description
JOB DESCRIPTION
This role is responsible for conducting in-process and final product quality analyses and inspections within a quality control laboratory in strict compliance with established standards and regulatory requirements within a global pharmaceutical manufacturing environment. The incumbent interprets and evaluates analytical results in terms of accuracy and precision against predefined specifications to ensure product integrity. Various measuring devices, testing equipment, and predetermined methods are employed to accept or reject products based on prescribed specifications. The role contributes to identifying ongoing quality issues and preventing potential production problems through proactive laboratory monitoring and timely escalation. Manufacturing process deviations and defects in finished goods are identified, documented, and reported in accordance with Good Manufacturing Practices. Random samples of finished goods are tested to verify conformance with internal and regulatory quality standards. The position supports continuous improvement initiatives by suggesting enhancements to laboratory testing methods and quality processes. It operates within a structured quality management framework aligned with 21 CFR Part 210 and 211, ICH guidelines, and applicable Indian and international pharmaceutical regulations.
Essential Functions
- Perform in-process and final product quality analyses and inspections within the QC laboratory in compliance with regulatory and internal standards
- Interpret and evaluate analytical results for accuracy and precision against established specifications
- Operate measuring devices, testing equipment, and follow predetermined methods to accept or reject products
- Test random samples of finished goods to verify conformance with quality specifications
- Report manufacturing process deviations and defects in finished goods to relevant stakeholders
- Identify ongoing quality issues and recommend preventive measures to avoid potential production problems
- Maintain accurate and complete documentation of all laboratory testing activities in accordance with GDP and GMP requirements
- Support implementation of corrective and preventive actions arising from quality investigations
Additional Responsibilities
QUALIFICATIONS
Education
- B. Pharm B. Pharm - Required
- M. Pharm M. Pharm - Preferred
Experience:
- 1 year or more in 1 - 4 Years
Specialized Knowledge: Licenses:
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