Primary responsibilities of this role include the following:
• Responsible for Packaging Development of Generic Formulations for Global Markets.
• Responsible for Preparation and Management of Packaging Related SOP`s as per cGMP regulations.
• Responsible for Management of availability of Packaging Material for Development Trials, Submission and Validation Batches.
• Responsible for Preparation of Packaging Development Report.
• Responsible for Preparation of Batch Packaging Records and Packaging Reports for Submission and Validation Batches
• Responsible for Identification and Alternate Source Packaging Material Development of Approved/Under Approval Generic Products.
• Responsible for Packaging Technology Transfer to In-house and CMO sites including Support for Trouble Shooting in Launch/Commercial Batches.
• Responsible for query response from regulatory and cross functional teams.