SATYANARAYANA NARASIMHA KUMAR Mutya (MSN KUMAR)
Hyderabad
Summary
Quality assurance professional with a strong background in pharmaceutical regulatory compliance and audit management. Demonstrated ability in root cause analysis and vendor auditing, contributing to continuous improvement efforts. Led successful US FDA audits, significantly improving operational standards and product quality.
Proven expertise in the analytical, qualification, facility creation, qualification, and compliance in analytical and manufacturing areas.
Instrumental in implementing the systems, training the team, and ensuring compliance.
Overview
21
21
years of professional experience
Work History
Deputy General Manager Quality Assurance
Sai Life Sciences
08.2017 - Current
- Developing and implementing quality assurance policies and procedures that comply with regulatory requirements
- Developing, implementing, and maintaining an effective quality management system (QMS) to ensure compliance with industry standards and regulations
- Investigating and resolving quality issues, including conducting root cause analysis, implementing corrective and preventive actions, and making necessary changes to processes or systems to prevent reoccurrence.
- Handling customer Audits, Visits and Regulatory Audits.
- Conducting vendor audits, including raw material and packaging component suppliers, service providers, contract manufacturers, and other vendors to ensure they are compliant with industry standards and meet company requirements.
- Providing guidance and oversight to ensure that standard operating procedures (SOPs) are followed, and quality measurements are implemented
- Ensuring compliance with regulations such as Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other standards set by regulatory bodies.
- Implementation of Computer system validation in accordance with GAMP5 regulation and compliance with respect to 21CFR Part11 and Annex11.
- Overseeing the document control process, which includes maintaining SOPs, batch records, analytical test methods, and other documents related to manufacturing processes.
- Developing and implementing quality improvement programs in areas such as process control, risk management, and deviation management to continuously improve the quality of products or services.
- Approving and releasing finished products for distribution, ensuring they meet specifications and regulatory requirements.
- Reporting quality metrics to management, outlining quality trends, issues, and opportunities for improvement.
- Providing training on quality management and regulatory compliance to personnel involved in manufacturing, quality control, and other related areas.
- Ensuring that all pharmaceutical products meet quality standards and are safe for human use.
- Reviewing documentation evidence covering identification of instruments, frequency of re-calibration, calibration status
- Successfully handled Two USFDA audits in QA lead role.
- Implemented the OOS and Audit management process as per guidelines.
- Electronic modules for the OOS and Audit management is designed to ensure end to end integration.
- Electronic data review and alarm review is implemented in Production applications and QC applications
Resource Manager
Dr. Reddy's laboratories
08.2004 - 08.2017
- Managed the lab compliance, LIMS implementation and Lab renovation
- Led the efforts to ensure lab compliance with industry standards, regulations, and safety protocols
- Supervised the implementation of a Laboratory Information Management System (LIMS) to improve data management and quality control
- Spearheaded a lab renovation project to improve the lab's infrastructure and equipment, enhance efficiency, and optimize workflow
- Ensured that the lab operations were aligned with the organization's goals and objectives
- Handled Specialized techniques like XRD,IC,AAS,ICP MS, PSA and lab support activities.
Education
M.Sc - Science
Ideal College of Arts And Science
Andhra Pradesh06-2004
B.Sc - Sciences
Aditya Degree College
Andhra Pradesh01.2002
Skills
- Quality Compliance/ Management
- System Improvement
- Audit Handling
- Root cause analysis
- Vendor auditing
- Laboratory compliance
- Training and development
- Problem solving
- Lab-Setup
- Risk Assessment
- GMP Compliance
- Pharma Regulatory Compliance
- ICH & GAMP5 Guidelines
- Testing & Validation
- Performance Management
- Analytical Method Validations
- Customer relationship management
- Employee development
- Global solutions
- Service quality improvement
- Cross-functional team management
- Vendor relationships
- Supply chain management
- Change implementation
- Team training and development
- Strategic planning
- Total quality management
- MS Excel
- MS Power Point
- MS Word
Languages
- English
- Telugu
- Hindi
Personal Information
Date of Birth: 04/19/82
Affiliations
- Recognized as the best IT enabler in QC
- Experience in the design and qualification of two laboratory QC labs designed and qualified
- Established 21 CFR compliance at analytical and manufacturing areas
- Strengthened quality management systems by upgrading the quality systems, such as out-of-specification, CAPA management, and document management systems
Timeline
Deputy General Manager Quality Assurance
Sai Life Sciences
08.2017 - Current
Resource Manager
Dr. Reddy's laboratories
08.2004 - 08.2017
M.Sc - Science
Ideal College of Arts And Science
B.Sc - Sciences
Aditya Degree College