We have urgent opening for Executive/ Sr.Executive - FR&D; (liquid & solid orals)
JD for Liquid Oral dosage form:
- Experience in formulation & Development of liquid oral dosage form (Solutions & Suspensions) in regulatory market (US/EU/Aus).
- To conduct literature search, patent search of assigned project and should be familiar with regulatory guidances.
- To prepare application for form 29, form 11, RLD import license, form 25 etc.
- To procure raw materials (API/Excipients), Packing material and Innovator samples in consultation with packaging/Regulatory & Purchase department.
- To execute pre-formulation and formulation optimization trials with QbD approach and develop a robust formulation.
- To manufacture batches for stability studies and perform other studies on optimized formulation.
- To review analytical reports and prepare compilation sheet and discuss with superiors.
- To co-ordinate with cross functional departments like Analytical, Regulatory, QA, MS&T; etc.
- To prepare Technology transfer documents like MFC, PDR, Stability Protocols, Risk assessment and execute scale up and Exhibit batches.
- 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