プロフィール詳細

プロジェクトを作成

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SUMAN K.に依頼

India

SUMAN PHARMA QUALITY AND REGULATORY EXPERT

プロフィール概要

Highly accomplished Quality Head (AGM) offering over 15 years of deep technical and operational expertise across multi-site pharmaceutical manufacturing operations. Proven capability in designing, governance, and remediation of end-to-end Quality Management Systems (QMS), encompassing complex deviations, CAPA systems, change controls, and thorough OOS/OOT investigations. Technical & Functional Expertise Quality Management Systems (QMS): Deviations, CAPA Management, Change Control Management, Out of Specification (OOS) & Out of Trend (OOT) Investigations. Validation & Qualification: Process Validation, Equipment Qualification, Cleaning Validation, Analytical Method Transfer. Technology Transfer: Scale-up & Technology Transfer (R&D to Commercial), Lab Batches Stability Evaluation, Manufacturing Readiness. Risk & Change Management: Quality Risk Assessment (QRA), Failure Mode and Effects Analysis (FMEA), Controlled Change Implementation. Domain Specialization API & Formulations: Comprehensive quality oversight spanning both Active Pharmaceutical Ingredients and finished dosage forms.

専門分野

• ☆ Health Technology Assessment
• ☆ Pharmaceutical Management
• ☆ Pharmaceutical Technology
• ☆ Non-GMO Products
• ☆ Product Evaluation
• ☆ Supply Chain & Logistics
• ☆ Inventory Control
• ☆ Stability Testing
• ☆ Shelf-Life Testing
• ☆ Quality Assurance & Quality Control (QA/QC)
• ☆ Product Validation
• ☆ Product Compliance
• ☆ Packaging Design
• ☆ Skills Training
• ☆ Regulatory Writing
• ☆ CMC Documentation
• ☆ NDA/BLA Applications
• ☆ Investigational New Drug (IND) Application Writing
• ☆ Technical & Scientific Writing
• ☆ SOP & Protocol Writing
• ☆ Spec Sheets
• ☆ Case Studies

サービス

• Writing
• Research
• Consulting
• Data & AI
• Product Development

Writing Clinical Trial Documentation, Non-Medical Regulatory Writing, Technical Writing, General Proofreading & Editing

Research Feasibility Study, Technology Scouting, Gap Analysis, Scientific and Technical Research, Secondary Data Collection

Consulting Digital Strategy Consulting, Legal Consulting, Operations Consulting, Scientific and Technical Consulting, Regulatory Consulting, Manufacturing Consulting

Data & AI Statistical Analysis, Image Processing, Image Analysis, Data Visualization, Data Insights

Product Development Formulation, Stability/Shelf Life Testing, Product Evaluation, Product Validation, Manufacturing, Quality Assurance & Control (QA/QC), Product Compliance , Product Launch Support, Packaging Design

職務経験

CQA QUALITY MANAGER

Piramal Healthcare Limited

- 現在

CQA MANAGER

Piramal Pharmaceutical

1月 2022 - 現在

学歴

MSC ORGANIC CHEMISTRY

Andhra university

6月 2010 - 3月 2012

認定資格

• Lean Six Sigma Black Belt

  Simplilearn

  https://certificates.simplicdn.net/share/4463835.pdf

  8月 2023 - 現在