We have urgent opening for Executive/ Sr.Executive - FR&D; (liquid & solid orals)

JD for Liquid Oral dosage form:

1. Experience in formulation & Development of liquid oral dosage form (Solutions & Suspensions) in regulatory market (US/EU/Aus).

2. To conduct literature search, patent search of assigned project and should be familiar with regulatory guidances.

3. To prepare application for form 29, form 11, RLD import license, form 25 etc.

4. To procure raw materials (API/Excipients), Packing material and Innovator samples in consultation with packaging/Regulatory & Purchase department.

5. To execute pre-formulation and formulation optimization trials with QbD approach and develop a robust formulation.

6.



To manufacture batches for stability studies and perform other studies on optimized formulation.

7. To review analytical reports and prepare compilation sheet and discuss with superiors.

8. To co-ordinate with cross functional departments like Analytical, Regulatory, QA, MS&T; etc.

9. To prepare Technology transfer documents like MFC, PDR, Stability Protocols, Risk assessment and execute scale up and Exhibit batches.

10. Address the regulatory queries.

Interested Candidate may send their resume on email Id : [email protected]

Regards,

Audrey Fernandes

Asst.Manager-HR

📌 Urgent Hiring | Executive/Sr.Executive- F&D (Solid and liquid orals) (Navi Mumbai)
🏢 Marksans Pharma
📍 Navi Mumbai