Assistant Manager

1 week ago

Indore, Madhya Pradesh, India Endo Full time

Summary Having wide experience in bulk manufacturing filtration and isolator filling line and able to manage plan for routine operations on vial filling line Having direct exposure of audit in last one year and understanding ability to maintain area and documents in compliance Operational Oversight Supervise and manage the compounding area operations including dispensing manufacturing and filtration activities Ensure all processes are carried out in accordance with standard operating procedures SOPs and regulatory requirements Monitor and maintain equipment and facilities to ensure they are in optimal working condition Team Leadership Provide guidance and support to team members ensuring efficient and accurate execution of daily tasks Foster a collaborative and productive work environment by addressing any issues or concerns that arise Conduct regular team meetings to review performance discuss challenges and implement improvements Training and Development Train new and existing team members on cGMP concepts GDP principles and departmental procedures Develop and deliver training programs to enhance team skills and ensure compliance with industry standards Evaluate training effectiveness and make adjustments as necessary to meet team needs Documentation Management Oversee the preparation review and approval of departmental documents including SOPs batch records and other critical documentation Ensure all documentation is accurate complete and compliant with regulatory standards Maintain proper documentation practices to support traceability and audit readiness Compliance and Quality Assurance Ensure adherence to cGMP and GDP regulations in all compounding activities Conduct regular audits and inspections to identify and address any compliance issues Implement corrective and preventive actions CAPAs as needed to resolve non-compliance and improve processes Continuous Improvement Identify opportunities for process improvement and implement best practices to enhance efficiency and quality Stay updated on industry trends and regulatory changes to ensure ongoing compliance and operational excellence

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