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 testing and timely escalation.
Manufacturing process deviations and defects in finished goods are identified, documented, and reported in accordance with Valuable 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 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 testing and analyses 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
Audit and monitor manufacturing processes and outputs against defined internal and regulatory quality standards
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 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