Job Responsibility :
Qualification : M.Pharm
Experience : More than 10 Years
- Experience in developing generic products for ANDA approvals to the USFDA and EU including solid oral dosage forms.
- Skilled in handling equipments like Rapid mixer granulators, Fluid bed dryers, Tablet compression and coating machines, Glatt GPCG 1.1 model etc.
- Strong knowledge of common pharmaceutical raw materials, their applications and the principles of formulation development.
- Well versed with scale-up and technology transfer process with an experience of Exhibit Batches conducted successfully as per cGMP guidelines in a US_FDA approved plant.
- Good understanding of Technology Transfer documents ( Test License, Pharmaceutics Development Report. Master Formula Card, Master Packing documents, Raw Material specifications, Finished products specifications, Standard Analytical Test Procedures, Stability Reports.
- Effective coordination with team by educating stringent means for routine product development activities.
- Co-ordination with QA-validation and Engineering departments for obtaining IQ/OQ/PQ reports of every machine and instruments in the premises of F&D departments.
- Good understanding of literature survey along with patents relevant for desired formulation development.
- To give technical support to regulatory affairs department in solving country specific product related queries.
- Coordinating with team members for smooth and faster development of projects.
- Preparation of Master Formula card and stability protocol.
- Formulation Development of solid oral Dosage forms for regulated market.
- Taking scale up batches and technology transfer demo batches.
Job Type: Full-time
Pay: ₹42,317.49 - ₹98,862.17 per month
Benefits:
- Health insurance
- Provident Fund
Experience:
- total work: 1 year (Preferred)
Work Location: In person
