Krishna Kotha

About Krishna Kotha

20+ years of experience in Pharmaceutical Quality Control and Assurance (14+ in Management) in Multi-National Companies with revenues over 2 Billion USD, catering to North American and European marketsStrong Working Knowledge of Pharmaceutical Quality Systems / Documentation, FDA Regulations / Guidance as they apply to Manufacturing, Packaging and QA/QC operations of Complex dosage formulations.Core Competencies• Strategic Planning, Budgeting and Resource Allocation• Talent Acquisition, Development and Management• Building and Leading High Performance Teams• FDA / Customer Audit Management, Response preparation and Closures• Collaboration with Internal / External customers, Business Partners and Third Party Consultants• Developing Quality / Confidentiality Agreements with Third Parties• Internal / External Audits and Vendor Qualification• Deploying Quality Management Systems and Procedures• Developing Quality Metrics, Strategies and advice Senior Management• Predict and Prevent Potential Quality Risks and Threats• Deviations, Complaints, Change and CAPA Systems Administration• Design controls and Risk management to support Drug-Device combination products.• Gap Analysis, Root Cause Analysis, Trend Analysis and Risk Analysis using statistical models and techniques• Field Alert, Market withdrawal and Recall Management• Electronic Quality and Productivity Systems Design, Deployment and Management• Process, Equipment and Facilities Validation• Raw materials, Finished Products, Stability testing and Method Validation• Knowledge of API and Excipient manufacturing operations.• Knowledge of NDA, ANDA and FDA regulatory processes.• Knowledge of DEA regulations and documentation

Experience

1. Director Technical Quality Assurance

   Organon

   Aug 2022 — Present

Education

• Sri Venkateswara University

  Master's degree, Chemistry

  1994 — 1996

• Acharya Nagarjuna University

  Bachelor's degree, Mathematics, Physics and Chemistry

  1991 — 1994

Skills

• Customer Service
• Pharmaceutical Industry
• Sop
• Fda
• Continuous Improvement
• Negotiation
• Change Control
• Microsoft Office
• Public Speaking
• Contract Manufacturing
• Research
• Windows
• Powerpoint
• Microsoft Excel
• Strategic Planning
• Regulatory Affairs
• English
• Gmp
• Teaching
• Quality Assurance
• V
• Validation
• Fda Gmp
• Capa
• Microsoft Word
• Quality System
• Quality Management