プロフィール詳細

プロジェクトを作成

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Surjit S.に依頼

India

Experienced Pharmaceutical QC Manager specializing in OOS/OOT investigations, analytical testing, and compliance

プロフィール概要

I am an experienced Quality Control professional with over 15 years in the pharmaceutical industry, specializing in analytical testing, OOS and OOT investigations, method validation, stability studies, and regulatory compliance. I have strong expertise in inhalation products, including metered dose inhalers, as well as oral solid dosage forms such as tablets and capsules. My work involves detailed root cause analysis, preparation and review of investigation reports, CAPA implementation, and support during audits and inspections. I am proficient in handling data integrity requirements, SOP preparation, and laboratory best practices in line with global regulatory expectations. I support organizations on a freelance and project basis by providing reliable, compliant, and practical quality solutions that help resolve critical issues and strengthen quality systems.

専門分野

• ★ Investigational New Drug (IND) Application Consulting
• ★ Quality Assurance & Quality Control (QA/QC)
• ★ Regulatory Writing
• ☆ Pharmacy
• ☆ Pharmacy Education
• ☆ Clinical Pharmacy
• ☆ Drug Development
• ☆ Pharmaceutical Manufacturing
• ☆ Extractable & Leachable Testing
• ☆ Pharmaceutical Process Development
• ☆ E-Health & Telemedicine
• ☆ Pharmaceutical Management
• ☆ Pharmaceutical Technology
• ☆ Investigational New Drug (IND) Application Writing
• ☆ Human Resources
• ☆ Workplace Investigations

サービス

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

Writing Medical Writing, Non-Medical Regulatory Writing, Technical Writing, Copywriting, Creative Writing

Research Market Research, Feasibility Study, Gap Analysis, Scientific and Technical Research, Systematic Literature Review

Consulting Healthcare Consulting, Operations Consulting, Scientific and Technical Consulting, Regulatory Consulting

Data & AI Statistical Analysis, Data Visualization, Big Data Analytics, Data Cleaning, Data Insights

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

職務経験

Manager

Glenmark Pharmaceutical

3月 2025 - 現在

MANAGER QMS

Glenmark Pharmaceuticals (India)

3月 2025 - 現在

学歴

Masters of Science

LOVELY PROFESSIONAL UNIVERSITY PUNJAB, INDIA

3月 2007 - 3月 2009

認定資格

• Certified Lead Auditor

  QUALITY GURU UK

  8月 2025 - 現在

• Certified Six Sigma Greenbelt

  SSA Solutions, Mumbai

  6月 2014 - 現在