Sr Executive II, Project Management

About the role

Responsible for leading Supplier Driven changes (SDC) Projects At ARPL, New Supplier Qualification (NSQ) Projects for NPD (New Product Development)/Product Life Cycle Management (PLCM) related to active pharmaceutical ingredients (APIs) and excipients.

What you'll do

• Initiate Change Controls in QMS Track Wise for Supplier Driven changes impacting New Product Launch and commercial APIs
• Demonstrate technical expertise to explain the API related issues to any technical, quality or regulatory teams and drive the discussion in conclusive manner
• Make sound technical decisions based on review of internal/external complex technical reports, interpret the data/issues
• Facilitate and drive the supplier driven changes and NSQ projects from the receipt of the changes till closure of CCRs through track-wise system
• Understand time-sensitive nature of managing changes by minimizing and/or eliminating delays within the critical path

What you need

• 5–9 yrs of experience
• Project management
• ISO 9001
• Regulatory affairs
• SAP
• GMP
• SOP writing
• M.Pharm