Rambabu Komati

About Rambabu Komati

24+ years of pharmaceutical experience in manufacturing, Quality & Regulatory, certified internal Auditor & Six sigma Qualified, Looking for Leadership roles in Corporate Quality & Compliance DQA-R&D & Site Quality & Regulatory Project management- Develop a robust control strategy during product development. Managing R&D Tech transfer activities to plant and CMO locations CoE SPOC for Robust product assessment for Nitrosamines impurities Provide guidance for control strategy for handling Genotoxic impurities. Regular monitoring of products Quality Risk Management through six sigma Regular gap assessment of regulatory observations Gap assessments Drug master files to market extension products Perform the process Quality Risk Assessment for new products and life cycle products. Design the specifications for new development products and approvals. Approval of Technical documents for submission to state FDA/CDSCO for product approvals DQA (CMC QA) SPOC for different exit stage gate clearance ex EB, DMF filling, and Query response. Conducting the Quality Review Board meetings Implementation of a robust Quality system in R&D Investigation and conclusion of OOS/OOTs for New & LCM projects. Approval of change control requests and ensuring the systematic closer. Handling of Deviations Monitoring of Corrective and Preventive Actions (CAPA) and prompt implementation of CAPA Preparation and Implementation of SOPs, Global Quality Standards Approve/Release Technology Transfer documents from R&D to manufacturing sites. Impart the regular training to the R&D team. Approval/release APIs for Pilot Bio-equivalence studies Conducting the Internal Audits in the GMP facility and Development labs Audit of contract testing laboratories (CTL) and CSP providers Approval of Analytical Method validation documents Monitoring and Review of Process validation activities for new products Handling of Stability studies Handling of Qualifications for equipment/instruments, facility, utilities, etc Review of Customer DMFs for outsourced APIS

Experience

1. Cmc Qa Functional Lead Rnd Baroda and Gurgaon (Senior Manager -1)

   SUN PHARMA

   Apr 2024 — Present

   Leading the Development Quality Assurance activities for Generic APIs, NCEs and Peptides

Education

• Madhya Pradesh Bhoj University

  M.Sc chemistry, Organic Chemistry

• ZPPS School, Kunchaparthy, Vemsoor Manadal, Khammam District

  Governement Degree College, Tiruvuru, Krihshna District, SSC

  1985 — 1993

• Acharya Nagarjuna University

  B.Sc, Maths, Physics and chemistry

  1996 — 1999

Skills

• Microbiology
• Computer System Validation
• Analytical Chemistry
• Verification and Validation (V&V)
• Cleaning Validation
• Auditing
• Generic Programming
• Standard Operating Procedure (Sop)
• Software Documentation
• Regulatory Requirements
• Capa
• Anda
• Formulation
• Biopharmaceuticals
• Regulatory Submissions
• Glp
• Life Sciences
• Calibration
• Dissolution
• Quality Assurance
• Corrective and Preventive Action (Capa)
• Ectd
• Uv
• 21 Cfr Part 11
• R&D
• Pharmacovigilance
• Technology Transfer
• Quality Control
• Gmp
• Quality Management
• Regulatory Affairs
• Validation
• Hplc
• Quality System
• V&V
• Change Control
• Pharmaceutical Industry
• Sop
• Fda
• Tqm