Bibek Kumar Hamal Radhe

Document Management

• Perform service requests in the systems such as ESOPs/ D2, CONDOR, SUBWAY, Up4Growth and any other tools, as needed.
• Assist in the process development and implementation, training and documentation for any new or existing business transition activities.
• Create and review GxP documents including SOPs, working procedures, trend reports, qualification reports and technical investigations.
• Escalate service related GxP and non-GxP issues and ensure timely investigation and compliance with local and global operating procedures.
• Ensure compliance to the internal quality standards, relevant regulatory requirements, filed product quality standards and service level agreements.
• Assist in implementing service quality and process improvement projects, CAPA management within Quality Service Centers.
• Assist in ad hoc administrative activities as per business requirements.

· Deviation Management: Capture, resolve, and track both supplier and internal deviations

· Change Management: To handle change controls and ensure the consistent and compliant change throughout the organization

· Complaint Management: Streamline complaint handling and regulatory reporting. To assist and active participate in the investigation of Batch failures, Market complaints and Product recall.

· CAPA Management: Implement a risk-based corrective and preventive action process for regulatory compliance.

· Audit Management: Ensuring Compliance for all Internal & External audit Observations.

· Out of specification/Trend Management: Ensure consistent out-of-specification lab result investigations.

· Assist in the investigation of Batch failures, Market complaints and Product recall.

· Training Management: Assist with training programs and provide hands on training to operators and workers.