Assistant Manager - Manufacturing
Endo
Date: 1 day ago
City: Indore, Madhya Pradesh
Contract type: Full time
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
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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