Officer - R&D ADL - Regulatory Query - 6372

18 hours ago


GUJARAT STAFF INDIA AHMEDABAD WEST VIROCHAN NAGAR Troikaa Group Full time ₹ 10,00,000 - ₹ 12,00,000 per year

Department: R&D analytical 

1. Sound Practical Knowledge of HPLC/UPLC method development, method validation for Assay and Related substance of injectable/complex injectable products. 

2. Experience in regulatory query handling and query responses. 

3. Sound practical knowledge of dissolution of USP-type IV instruments method development and method validation for complex injection and evaluation of the analytical data. 

4. Sound knowledge of analytical instruments like Viscometer, Rheometer with analytical data interpretation, Gel permeation chromatography (GPC) for molecular weight determination etc. 

5. Routine Analysis of raw materials, intermediates and finished products. 

6. Good hands on experience of drug excipient compatibility study and evaluation of analytical data. 

7. Knowledge of different tests like Assay and Related Substances by HPLC, Dissolution by HPLC, Blend Uniformity, Content Uniformity, Osmolality, Particle Size Distribution etc. 

8. Good knowledge and practical hand of reverse engineering to find out the identification and quantification of chemical composition of innovator samples (Q1&Q2). 

9. Ensure work environment clean and safe in compliance with safety guidelines. 

10. Ensures that all executed and documented activities are aligned as per company policies and objectives. 



  • ahmedabad, India Troikaa Group Full time

    Department: R&D analytical 1. Sound Practical Knowledge of HPLC/UPLC method development, method validation for Assay and Related substance of injectable/complex injectable products. 2. Experience in regulatory query handling and query responses. 3. Sound practical knowledge of dissolution of USP-type IV instruments method development and method validation...

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