Rashmiranjan Pati

Compliance:

• Expertise in ensuring high quality standards and regulatory compliance in the manufacturing of Solid oral formulations by conducting Audits periodically and as and when required.
• Participating in vendor Audits, preparation of Audit report, assessment of compliances and closure of audit.
• Spearheading comprehensive remediation efforts for manufacturing plant, ensuring they meet and exceed quality standards.
• Monitor and review the updates in various regulatory guidelines.
• Evaluation of regulatory updates, relevant warning letters, FDA-483 observations with respect to site controls and take action wherever necessary.
• Evaluation of guidelines and their implementation status across site with respect to ISO, Health Canada, FDA, EMEA, MHRA, TGA etc...
• Advocating data reliability and integrity and its compliance at plant level and performing investigations for violations /potential violations of data integrity.
• Operations:
• End to end responsible for continuous manufacturing compliance for the manufacturing block.
• Usage of appropriate risk management tool to identify areas of improvement.
• Evaluation of validation requirement for the product and process.
• Ensuring online documentation and its correctness
• Championed company-wide diversity and inclusion initiative, creating more supportive and innovative work environment.
• Evaluated employee performance and conveyed constructive feedback to improve skills.
• Established team priorities, maintained schedules and monitored performance.
• Defined clear targets and objectives and communicated to other team members.
• Developed and executed successful training program for junior managers, equipping them with essential leadership skills.
• Leading resource planning for optimizing man & resource utilization, reducing wastes for profitability by guiding team members while continually building quality and compliance.
• Maintained positive customer relations by addressing problems head-on and implementing successful corrective actions.
• Recruited, interviewed and hired employees and implemented mentoring program to promote positive feedback and engagement.
• Assisted in organizing and overseeing assignments to drive operational excellence.
• Cultivated positive rapport with fellow employees to boost company morale and promote employee retention.
• Streamlined and monitored quality programs to alleviate overdue compliance activities.
• Managed senior-level personnel working in marketing and sales capacities.
• Established performance goals for employees and provided feedback on methods for reaching those milestones.
• Previous role:
• Ensuring execution of the market complaint in compliance with the regulatory requirements with timely completion of complaint record. Monitoring of the CAPA implementation and its effectiveness check.
• Assess the requirement of recall and take appropriate action as necessary.
• Filling of initial / Follow up and Final Field Alert report.
• Participating in Vendor Audits and provide necessary support for qualification and approval of the Manufacturer as per regulatory requirement. Assessment of vendor based on data, documents & Audit report.
• Monitoring deviations for their proper investigation and verification of the implementation of corrective and preventive action timely and evaluation of repetitive deviations.
• Participating in failure investigation (out of specification) followed by conducting analysis of the problem and identifying root causes.
• Ensuring the requirements of Annual product reviews of all drug products are met and evaluate for the requirement of any improvement in the existing system.
• Evaluation & verification of change controls for its methodology of implementation and impact assessment of the proposed change.
• Ensuring the Investigation of product complaints are adequate and implement appropriate CAPA wherever applicable.
• Evaluate the requirement of Field Alert report and Recalls.
• Periodically monitoring the performance indicators of the Quality management system to evaluate the health of the unit through Quality Metrics.
• Participating in Quality management review and escalation of the issues to the higher management. Follow up and implementation of the suggestions or corrective action suggested by senior management, continual improvement of the quality system.
• Planning, organizing, directing, & controlling quality management system through business excellence and continuity philosophy.
• Monitoring and ensuring conformity of the established regulations; maintaining quality standards and effectuating continuous improvement to enhance process capabilities
• Steering in-house mock audits to ensure compliance with cGMP requirements.
• Ensure the adequacy of line clearance at manufacturing and packaging stages.
• Ensuring that manufacturing and packing operations are being carried out as per approved batch production records.
• Ensuring that the in-process checks are performed as per the Batch record instructions.
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• Reporting to the Senior General Manager

• Reported to the Unit QA Head

• Reported to Sr. Executive