Sudhakar Pathak
Lead Quality Assurance
- Role
- Lead Sr Manager Quality Assurance at Dr. Reddy's Laboratories
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Sudhakar Pathak
About 17 years experienced quality professional, my role as Lead/Manager Quality…
Experience
Lead Sr Manager Quality Assurance
Dec 2022 — Present · IN
Engineering & ITQA Leadership: Oversee engineering activities for modification, expansion, and revamping projects.Commissioning, Qualification, and Validation: Lead commissioning, qualification, and validation efforts for new equipment, utility, systems, and processes.FAT (Factory Acceptance Testing): Ensure successful execution of Local & Overseas FAT for new equipment, utility and systems.Quality Management System: Implement and maintain a quality management system (Change Control, Deviation, Lab Incident, Investigation, CAPA) that meets regulatory requirements and industry standards.Risk Management: Identify, assess, and mitigate risks associated with product quality, patient safety, and regulatory compliance.Audit Readiness: Ensure constant readiness for internal and external audits, including regulatory inspections.Regulatory Compliance: Ensure compliance with relevant regulations, such as FDA, MHRA, EU, and WHO guidelines.GEMBA Walk: Lead GEMBA walks to identify areas for improvement and implement changes to enhance product quality and process efficiency.Computer System Validation: Validate computer systems, including software and hardware, to ensure data integrity and regulatory compliance.ITQA (Information Technology Quality Assurance): Ensure IT systems and infrastructure meet quality and regulatory requirements.Project Management: Manage engineering and ITQA projects, including resource allocation, timelines, and budgeting.Team Management: Lead and develop a team of engineers and ITQA professionals, providing guidance and training as needed.Communication: Collaborate with Third party/OEM, cross-functional teams, including Projects, Manufacturing, Quality, and Regulatory Affairs.Quality Metrics: Develop and track quality metrics to measure performance and identify areas for improvement.Continuous Improvement: Identify areas for improvement and implement changes to enhance product quality, process efficiency, and regulatory compliance.
Education
SRI SATYA SAI UNIVERSITY OF TECHNOLOGY & MEDICAL SCIENCES, SEHORE
Master of Pharmacy
Rajiv Gandhi Prodyogiki Vishwavidyalaya
Bachelor of Pharmacy
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