ANUPAM KUMAR MISHRA

Results-driven Sr. Manager QA with over 18 years of experience in developing and maintaining Quality Management Systems in regulated pharmaceutical environments. Expertise in policy development across product lifecycles, project management, and facility qualification. Skilled in regulatory audit management, including USFDA, EU, and other global agencies.

Experienced with strategic planning, team leadership, and operational management. Utilizes comprehensive business acumen to drive efficiency and innovation. Track record of fostering collaborative environments and achieving high-impact results.

Leading the Team of 60-70 personnel

• Green Field Project
• Policies and procedures design
• SOP simplification and harmonization
• Quality system design and implementation
• Project Management as QA Head from Plant Designing, Commissioning and Qualification for Europe market.
• Handling of Regulatory Audits (USFDA, MHRA, ANVISA, TG, PICs and Regulatory Markets)
• Product Complaint Handling
• Change control Management
• Deviation Management
• OOS/OOT Handling
• Vendor Management
• Validation master plan
• Quality Risk Management
• Cleaning validation
• Equipment Qualification
• HVAC validation
• Facility Design and Qualification
• Water system validation
• Site master file Review and Approval
• Quality Review Management Meeting
• Quality matrix and site Performance evaluation
• Handling of customer Audits.
• Handling of Internal audit
• Computerized System Validation
• Training Management
• Process validation
• Hold time study
• ISO Audit (ISO 9001:2015, ISO 45001:2015 & ISO45001:2018)
• FSSAI Audits
• In-Process Quality Monitoring and Control
• Regulatory Submission