Description:
This role is responsible for conducting in-process and final product quality analyses and inspections 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 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 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 in compliance with regulatory and internal standards
- To perform all quality control activities with compliance to cGxP for instrumental, chemical and physical analysis.
- To prepare and standardize volumetric solutions and reagents.
- To perform daily verification of laboratory equipment and maintain its record.
- To ensure the training on relevant SOPs and instruments before execution of the activities.
- To compile, review and evaluate analytical results/data as required by the SOPs.
- To analysis of Finished Product, In-process and Stability samples as per respective STPs/SOPs/Specifications & Pharmacopoeia requirement as applicable.
- To operate various analytical instruments like but not limited to UV-VIS spectrometer, KF titration, Dissolution test apparatus, Autotitrator, FTIR spectrometer, HPLC , GC.
- 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:
