Sun Pharma

To author and review quality agreements between Sun Pharma & CMO site. Also, ensure qualified and approved external service providers are used.

OE Lead would be a key resource working closely with the Sun Global Operations leadership to identify, analyse and resolve manufacturing issues and align supply to business demand

This position will support and manage the regulatory activities associated with the Chemistry, Manufacturing and Controls for New Drug Applications across globe. Regulatory activities focus on filing activities/query responses/post approval changes as suggested across globe.

Sterile operation, Microbiology with quality management system understanding. Internal audits with updation in current guidelines. CAPA management and effective implementation.

Monitoring for Documents compilation activities for New product filing , Re-Registration, renewals from plant dossier filing , sample requirements etc. Participation in Action plan discussion for queries from different Regulatory agencies and monitoring for submission of data, documents from plant.

Exposure in investigation of UPD , OOS, OOT, EM and Change control and CAPA Management Preferable for exposure in Regulatory and FDA Audits.

Should have knowledge of formulation development, statistics, statistical tools and knowledge of regulatory guidelines/requirements

Sterile manufacturing Suspension/emulsion /PFS / BFS as well as SKID operation. Should have experience in Aseptic process, complex manufacturing, Exposure to CIP/ SIP SKID, QMS.