Assistant Manager - Manufacturing chez Endo

Job Description 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.

Job Description

• 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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