Job Description
Designation : Executive / Sr. Executive
Position 02
Job Responsibilities ;
This is pure documentation role from F&D perspective where candidate will be working for F&D documentations.
Candidate must have exposure in formulation & development of dosage form (OSD / Injectable).
Experience in Formulation Development of solid oral dosage forms with a very good understanding of all facets of Formulation development.
Optimization of the formulation process parameters and trouble shooting in solid oral dosage forms.
- Literature survey, pre-formulation studies and formulation trials leading to identifying a suitable composition for the product.
- Identification and optimization of suitable process parameters and components for manufacturing the product.
- Formulation development (QBD) for regulatory and near regulatory markets.
- Preparation of SOP's, PDP's, Product Specifications Protocols, Reports and PDR (QBD) etc.
- Development and Scale up of products and optimization of the process.
- Conducting the stability studies for new products.
- Supervision of the exhibit/pilot batches manufacture.
- Preparation of technical regulatory documentation to support development work and manufacturing (includes protocols, reports, laboratory note books and batch records) to internals.
- Conducting of CFT's with other supporting departments to reduce the gaps and fast moving of projects.
- Complex dosage forms instead of OSD like, Peptides, Transdermal, Injections, Cream, Ointment etc.
- Experience with 505 (b)(2) or NDA / IND is preferred.
Joiners who can join us in 30 days would be a preference .