The ideal candidate must have hands-on exposure to ophthalmic formulations, along with practical experience in autoclave operations and batch manufacturing processes. A strong understanding of GMP and quality compliance is essential.
Compilation of high quality Annual Product Reviews / Product Quality Reviews for products manufactured at various manufacturing sites and retrieve data from the Quality and regulatory databases and system
Responsible for execution and review support of Quality Assurance activities including document review, shop-floor QA support, deviation handling, and quality systems support to ensure compliance with cGMP and regulatory requirements.
Review and approval of analytical documents, raw data, audit trails, calibration/PM records, analyst qualification documents, and reference/working standard qualification records in compliance with GMP and data integrity requirements.
Exposure of analysis for Finished Products. Stability Samples & Raw Materials. Having Knowledge of Analytical Method Validation. Verification & Method Transfer. Having skill for data interpretation, troubleshooting.