Job Description
• Review analytical methods for APIs and finished pharmaceutical products.
• Review analytical method validation protocols and validation study reports.
• Review API and finished product specifications, limits, and acceptance criteria.
• Review stability study data and shelf-life justifications in line with ICH guidelines.
• Review DMF analytical sections and critical API quality attributes for compliance.
• Verify analytical compliance for BE study sample testing and reporting activities.
• Identify analytical documentation gaps impacting regulatory acceptability.
• Relevant experince in Quality control or Regulatory Affairs.
• Verify alignment of analytical data with CTD Module 3 structure and expectations.
• Maintain accuracy, traceability, version control, and integrity of analytical records.



Requirements
• Bachelor’s or Master’s degree in Pharmacy is mandatory.
• Minimum three years experience in QC or analytical validation roles.
• Hands-on experience reviewing analytical method validation documentation.
• Sound working knowledge of ICH guidelines and pharmacopeial standards.
• Strong analytical data interpretation and technical documentation review skills. Benefits
• Remote working option with defined review responsibilities.
• Adaptable

working hours
aligned to dossier and submission timelines.
• High technical ownership without laboratory or shop-floor operations.

📌 Senior Executive (Dehradun)
🏢 Rhydburg
📍 Dehradun