Experience
3 - 5 yrs
Job Location
India
Vacancy
1
Designation
Formulation & Development Executive
Job Type
Not specified
Job Description
- Responsible for formulation and process development of oral immediate-release dosage forms, including oral film and tablet formulations.
- Troubleshoot and problem - solve , unresolved or new formula issues.
- Design and execute formulation trials, analytical testing and evaluate stability data to finalize formulation composition.
- Develop manufacturing processes for R&D formulations so that the technical transfer is successful for large scale batches.
- Responsible for all formulation/ process related CMC documents which will be part of regulatory filings.
- Write/review master formulas, manufacturing procedures, SOPs, stability protocols/ reports, process validation protocols/reports, Product Development Reports, QOS, QbR etc.
- Preparing pharmaceutical development reports, manufacturing formula records (MFRs), Tech transfer, SOPs, guidelines for all processes, documentation and process validation and coordination with production for validation batches
- Support technology transfer for manufacturing processes from laboratory scale to production scale.
- Supervising material management in F&D
- Work with Analytical Method Development, Regulatory Affairs, Quality Control, Quality Assurance, Inventory Control etc. to expedite the development and approval of new products by FDA.
Pedigree
- 3-5 years of relevant work experience in R&D Formulation Development Department
- B.Pharm / M.Pharm
No Referrers Available
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