Profile Details

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Hire Surjit S.

India

USD 40 /hr

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

Profile Summary

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.

Subject Matter Expertise

• ★ 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

Services

• 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

Work Experience

Manager

Glenmark Pharmaceutical

March 2025 - Present

MANAGER QMS

Glenmark Pharmaceuticals (India)

March 2025 - Present

Education

Masters of Science

LOVELY PROFESSIONAL UNIVERSITY PUNJAB, INDIA

March 2007 - March 2009

Certifications

• Certified Lead Auditor

  QUALITY GURU UK

  August 2025 - Present

• Certified Six Sigma Greenbelt

  SSA Solutions, Mumbai

  June 2014 - Present