Roles and ResponsibilitiesEnsure compliance with regulatory requirements for API manufacturing, bulk drugs, and ECTD submissions.Prepare dossiers for US FDA, EU GMP, and other international markets.Coordinate with cross-functional teams for timely submission of applications.Maintain accurate records of regulatory documents and updates.Provide guidance on drug regulatory affairs to internal stakeholders.

Roles and ResponsibilitiesPerform breakdown maintenance, electrical maintenance, mechanical maintenance, process engineering, preventive maintenance, and utility maintenance tasks to ensure smooth plant operations.Troubleshoot issues related to equipment failures and implement corrective actions to minimize downtime.Collaborate with cross-functional teams for effective project execution and problem-solving.Ensure compliance with safety protocols and maintain a safe working environment at all times.Monitor production processes and identify areas for improvement.