Job Title: Research & Quality Assurance (QA) - Excipients

About the Role

We are looking for a detail-oriented and technically robust Research & QA skilled to manage regulatory documentation, technical support, and qualification processes for pharmaceutical excipients. The role involves extensive interaction with global manufacturers and leading pharmaceutical clients.

Key Responsibilities: Regulatory & Technical Documentation
Handle and manage complete regulatory documentation for pharmaceutical excipients.
Prepare in-house technical documents required for the promotion and qualification of excipient products.
Provide specific technical documents required for manufacturer and product qualification.
Prepare qualification documents for pharmaceutical companies in line with excipient requirements.
Work on USP/EP/JP monograph comparisons for various excipients and in-actives.

Technical Support
Resolve technical queries raised by major pharmaceutical clients.
Manage technical matters and documentation-related tasks for excipient manufacturers.




Support regulatory qualification and address related queries for excipients/inactives.

Coordination & Stakeholder Management
Coordinate with overseas manufacturers of excipients/in-actives regarding technical and regulatory requirements.
Handle virtual audits conducted by pharmaceutical customers for excipient qualification.
Manage the end-to-end Vendor Qualification Process for excipient raw materials.

Requirements:
Bachelor’s or Master’s degree in Pharmacy (B. Pharma/M. Pharma), Biotechnology, Science, or related fields.
Robust understanding of pharmaceutical excipients, regulatory guidelines, and documentation practices.
Familiarity with GMP, GDP, ICH guidelines, and excipient qualification processes (preferred).
Excellent communication, documentation accuracy, and technical interpretation skills.
Remuneration and benefits will be best in industry. _

Pay: ₹18,000.00 - ₹50,000.00 per mo

📌 Research & Quality Assurance Qa Excipients Ahmedabad
🏢 Planet Science
📍 Ahmedabad