SRA /Executive( OSD ) FD
R&D Center In Ambarnath
- Posted: 4 months ago
- Openings: 10
- Applicants: 0
Job Description
We require CVs for following position
VACANCY: Sr. Research Associate /Executive(OSD) FD
LOCATION: Ambernath
The candidate should be M. Pharm /PhD
Experience 5 Years -8 years
Required Skills- OSD (IR,ER,DR),
(FD-Reg market)
ob Overview:
We are seeking a highly skilled and experienced Formulation Development Scientist specializing in solid oral dosage forms. The ideal candidate will have extensive knowledge of immediate, extended, and delayed-release formulations, and be proficient in Quality by Design (QbD) principles, Process Development Report (PDR) preparation, and technical document creation.
Key Responsibilities:
1. Lead the formulation development for solid oral dosage forms, including immediate-release, extended-release, and delayed-release products.
2. Design and execute experiments for formulation development, optimization, and scale-up and exhibit batches.
3. Prepare and review technical documentation, including Initial Product Specifications (IPS), Final Product Specifications (FPS), stability protocols, Master Formula Records (MFR), and scale-up protocols and reports, PDR etc.
3. Collaborate with cross-functional teams, including analytical development, quality assurance, regulatory affairs, and manufacturing.
4. Ensure compliance with regulatory requirements and guidelines (FDA, EMA, and other regulatory bodies) throughout the development process.
5. Utilize Quality by Design (QbD) principles to ensure robust and reproducible formulations.
6. Conduct stability studies and interpret data to ensure product stability and shelf-life.
7. Troubleshoot formulation issues and provide technical support for ongoing projects.
8. Stay updated with the latest advancements in formulation science, technologies, and regulatory requirements.
Please send your resume to contact@magneepharmaconsultants.com OR
WhatsApp on+91-8369789347
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