Executive Supervisor - Injectable

Alembic Pharmaceuticals Limited; Vadodara; On-site; INR 600,000 - 850,000; Full time

Job summary

Alembic Pharmaceuticals Limited is seeking a qualified professional to oversee URS preparation, review and approval for all manufacturing equipment, and analysis of vendor technical offers. The role covers qualification/validation activities, ensuring cGMP compliance and safety across manufacturing processes.

Responsibilities include coordinating with MS&T for product transfers, scale-up, batch records, SOPs, and training documentation to maintain compliant, efficient operations on site in India.

Responsibilities

• Preparation, review and approval of URS for all manufacturing equipment, analysis and comparison of technical offers from vendors.
• Troubleshooting, ongoing technical process validation, continuous process verification and process improvement.
• Implementation of cGMP and safety at all stages of manufacturing activities.
• Preparation, review of qualification/validation documents and execution of qualification/validation activities.
• Reviewing the equipment P&ID, area layouts.
• Review and approval of Equipment validation, Process validation, Process simulation documents.
• Coordinate with MS&T for product transfer and execution of scale up and Registration batches.
• Preparation, review and approval of process flow diagrams and component specifications as per process requirement.
• Responsible for preparation, review and approval of SOPs, operating instructions, and cleaning Instructions.
• Responsible for the preparation, review and approval of Master Manufacturing Record and Batch Manufacturing Record.
• Organize and co-ordinate training activities, preparation of documents and maintenance of training records.

Job description

• Preparation, review and approval of URS for all the manufacturing equipment, analysis and comparison of technical offer received from various vendors.
• Responsible for the trouble shooting, ongoing technical process validation, continuous process verification and process improvement.
• Implementation of cGMP and safety at all stages of manufacturing activities.
• Preparation, review of qualification/ validation documents and execution of qualification/ validation activities.
• Preparation, reviewing and approval of the new equipment (FAT & SAT) & equipment Risk Assessments, URS, DQ, FDS, IQ, OQ and PQ documents.
• Reviewing the equipment P&ID, area Layouts.
• Review and approval of Equipment validation, Process validation, Process simulation documents.
• Coordinate with MS&T for product transfer and execution of scale up and Registration batches.
• Preparation, review and approval of process flow diagrams and component specifications as per process requirement.
• Responsible for preparation, review and approval of standard operating Procedure (SOPs), operating instructions, and cleaning Instructions.
• Responsible for the preparation, review and approval of Master Manufacturing Record and Batch Manufacturing Record.
• Organize and co-ordinate training activities, preparation of documents and maintenance of training records. Oversee daily operations during the assigned shift.
• Ensure smooth transition between shifts, maintaining continuous production flow.
• Ensure documentation is up-to-date and compliant with standard operating procedures.
• Audit Compliance
• Handling of regulatory audit