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Responsible for review of User Requirement Specification, Design Qualification, FAT Protocols. SAT Protocols, Installation Qualification, Operational Qualification, Performance Qualification Protocols and reports

You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments

Having Knowledge of HPLC, GC, IR, UV and other analytical instruments. Having Knowledge of Analytical Method validation and developments

Must have PhD, Medical degree or Master’s degree (MSc, M Pharm, Pharm D or equivalent) combined with relevant experience.

Managing site and user access across clinical data management systems such as EDC and eCOA platforms.

These services are essential for regulatory compliance and successful trial outcomes. They often utilize specialized software and systems to manage the data efficiently.A critical phase in clinical research that assures collection, integration and availability of data at appropriate quality and cost.

Supervision of manufacturing, processing, packaging and holding of drug product as per define and approved procedures for stability batches and commercial batches.

Handling of HPLC, GC, UV and Dissolution & other sophisticated instruments 

To propose and fix the batch size i.e. of the Demo, Scale up, Exhibit and Commercial based on Equipment Capacity/Qualification, Scale Up factor calculations & annual requirements.