Validation professional with expertise in qualification / validation / re-qualification of instruments, equipment & utilities; hands-on validation through electronic systems; calibration & preventive maintenance.
The First Line Leader is accountable for developing and enabling a frontline team of operators to consistently deliver exceptional safety, quality, service and cost‑effective products.
The Manager - IT CSV is responsible for end-to-end oversight of Computerized System Validation, equipmen/ utility qualifications, audit support, and quality systems compliance in a GxP-regulated pharmaceutical environment.
Program Manager- R&D Transformation & Productivity, you will play a key role in supporting the execution of strategic transformation initiatives across the global R&D organization. Dr. Reddys Laboratories
Support Medical Affairs objectives for assigned Cardio-Diabetes / Specialty therapies in emerging markets. Provide scientific and clinical inputs using current guidelines, clinical data, and real-world evidence.
Contribute to preparation and delivery of regulatory submissions from a global and regional perspective. Preparation and review of Marketing Authorization Applications & Variations for filing in US, EU, Japan, Canada Switzerland, Australia.
Responsible for one or several of the following: processing of Individual Case Safety Reports (ICSRs) from various sources, Literature search and review, signal detection and management, tracking regulatory information