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

About the Role

We are looking for a detail-oriented and technically strong Research & QA professional 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