U.Manmohan Patro

• Oversaw broad spectrum of quality assurance functions including In-Process Quality Assurance (IPQA), Change Control, Annual Product Quality Review (APQR), and Validation (including Computer Systems Validation (CSV)).
• Prepared and reviewed all CSV documents related to software/applications.
• Developed and executed validation documents such as Validation Plans, System Requirement Specifications, Risk Assessments, Installation Qualifications, Operational Qualifications, and Performance Qualifications.
• Authored key validation deliverables including Validation Plans, Test Plans, and Summary Reports.
• Conducted GxP analysis, Gap assessments, and implemented mitigation actions.
• Managed CAPA deviations and Change Control processes.
• Ensured all processes complied with global regulations including GAMP 5, 21 CFR Part 11, and EU Annexure 11.
• Assisted in 21 CFR Part 11 assessments

• Led In-Process Quality Assurance (IPQA) activities for tablet and topical preparations, ensuring regulatory compliance and maintaining rigorous quality control during manufacturing and packaging.
• Managed batch release procedures, executed Change Control processes, and conducted comprehensive reviews of unit operations.
• Oversaw Master Batch Production Record (BPCR) evaluations and supervised sampling protocols for finished and intermediate products.
• Implemented Track and Trace systems and administered user ID lifecycle management, ensuring compliance with 21 CFR regulations.
• Provided QA oversight for drug substance manufacturing, including:

Process validations
Cleaning validations
Batch release activities
Process investigations
OOS/OOT investigations
Deviation management
CAPA implementation
QMS activities

• Managed In-Process Quality Assurance (IPQA) activities for both Tablet and Soft Gelatin Capsule manufacturing and packaging, enforcing strict quality standards.
• Conducted Batch Manufacturing Record (BMR) and Batch Production Record (BPR) reviews.
• Executed Change Control activities to ensure quality throughout production changes.
• Supervised Data Logger operations for accurate data collection during manufacturing.
• Maintained compliance with sampling protocols for intermediate and finished products.
• Provided QA oversight for drug substance manufacturing, including:

Process validations
Batch release activities
Cleaning validations
investigations
Deviation management
Corrective and Preventive Action (CAPA) implementation
Quality Management System (QMS)