4-5

B.Pharm / M.Pharm / M.Sc . Expertise in analysis on HPLC, GC, Assay, Dissolution. Method Validation Protocol creation and execution, Expertise in handling HPLC, ICPMS, GC etc. USV Private Limited

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.

Handling of Contract Service Provider. Facilitate for timely preparation, review and adequate response to the Observation and monitor CAPA planner for it timely closures. 

Comply with internal and external timelines for managing adverse events and product complaint case processing, and case submission processes as appropriate. 

Bachelors degree or equivalent in a relevant field, such as Pharmacy, Sciences, Medical or Bio related

Knowledge of Injectable plant in Validation of injection filing line, Lyo, Autoclave, DHS etc & Knowledge of QMS