Job Description

Core Job Responsibilities:

• Development of formulation to create a reproducible prototype formulation.
• Ensure Proper documentation of all formulation trials in the lab note books and then using the information for creation of the Product Development Report for use in dossier for filing.
• Use of QbD and DOE wherever required for Product and process optimization.Ensure robustness of the developed formulation at engineering scale as well as commercial scale.
• Preparation of Pharmaceutical Development report for Quality module of CTD.
• Literature Search
• Preformulation studies
• Preparation of the Transfer documents
• Technology transfer at production site

Key Deliverables:

• Preparation of project documents for filing (stability protocols, PDR, BMR, MMD, and Validation batch etc.) for the regulatory filing
• Preparation of the Transfer documents
• Technology transfer of all the variants of injectable dosage forms from R&D to production/commercial site,
• Follow GDP

Functional/ Technical: * Formulation and Product Development

• Schedule and follow all the steps to deliver the drug as per QTPP
• Select the suitable polymers / excipients based on either properties or scientific rationale
• Pharmaceutical Development Report (PDR)
• Prepares PDR /DOE report as per Common Technical Document (CTD) module 3 requirements
• Complies with regulatory requirements as defined in QTPP

Other Detalis :

• Designation - Product Development Contingent Worker (Injectable)
• Qualification \xe2\x80\x93 M.Pharma
• Experience : 1 Years
• Work Timings \xe2\x80\x93 8.30 am \xe2\x80\x93 5.30 pm
• Working Days \xe2\x80\x93 Monday - Saturday
• Work Location \xe2\x80\x93 MIDC, Andheri

Payroll company- Talisman HR Solutions PVT LTD (Third Party Payroll)

Talisman HR Solutions