Senior Executive - Production (Investigation & Market Complaints)

Role & responsibilities

• Shop-Floor Investigation: Lead technical shop-floor investigations for all manufacturing and packaging defects flagged by market complaints (e.g., tablet chipping, leaking blisters, volume variations, particulate matter).
• Batch Document Forensics: Perform deep-dive reviews of Batch Manufacturing Records (BMR), Batch Packaging Records (BPR), machine logbooks, and equipment calibration states to isolate operational anomalies.
• Process Simulation: Design and execute controlled process simulations or trials on the shop floor to replicate the failure mode reported by the customer.
• Root Cause & CAPA Implementation: Partner with QA to conduct Root Cause Analysis (RCA). Own the execution of engineering and process-driven CAPAs on the line (e.g., modifying SOPs, upgrading machine tooling, or revising process parameters).
• Cross-Functional Troubleshooting: Coordinate directly with Plant Engineering, Maintenance, and Quality Control to audit equipment performance related to complaints.

Preferred candidate profile

Education: B.Pharm / M.Pharm

Experience: 36 years of core experience in Pharmaceutical Production Operations with a heavily proven track record of handling deviations, incidents, and market complaint investigations.