Discussion forum for Pharma Quality events, Regulatory Actions
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Warning letters, 483s, Recalls, Import Alerts, Audit observations
• Coordination with R&D for the technology transfer of the process.
• Handling of Intensification trials, lab equipment's and instruments.
• Trouble shooting of the process with coordination of CFT.
• Monitoring the process efficiencies.
• Plant and Machinery modifications or Improvements. Providing resources for implementation related to the process.
• Technical and Scientific support to manufacturing operations, resolution and reduction of process deviations, development and implementation of corrective / preventive actions.
• Identification of process development initiation in bulk products for capacity enhancements, solvent recovery and yield improvement. • New facility creation and modification in the existing facility for the running molecules.
• Co-ordination with other department related to Process engineering activities.
• Plant and Machinery modifications or improvements.
• Costing and Budgeting for Production Department.Â
• Authorized to review quality documents (MFR, SOP's , study reports & qualification documents).
• Responsible for giving objectives and proper utilization of down the line production personnel Guiding function related to operation for better CGMP and Production.
• Authorized for imparting training in QMS documents to own departmental employees and other department employees.
BTech
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