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.

• 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.

Skills Required