Product Development Contingent Worker (Injectable)
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 – M.Pharma
- Experience : 1 Years
- Work Timings – 8.30 am – 5.30 pm
- Working Days – Monday - Saturday
- Work Location – MIDC, Andheri
Payroll company- Talisman HR Solutions PVT LTD (Third Party Payroll)
Key Skills :
Company Profile
Our client is an American MNC Pharmaceutical Company.
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