Date PostedDecember 22, 2022
Location (State / UT)
Experience2 Years, 6 Years
Desired QualificationMaster’s Degree
- Preformulation Studies/Prototype development: Literature survey, Reference product Characterization, Drug /Excipients compatibility, Procurement of tooling, Selection of prototype composition & process based on the dissolution results, stability data compilation, and design of experiments. Recording the observations of the trial in the laboratory notebook and compilation of data
- Submission of application for test license, Import license, and manufacturing license.
- Lab scale development: Optimization of prototype composition and comparison of multimedia dissolution with that of reference product by conduction of lab scale trails
- Pre-Validation Batch: Planning and releasing purchase requisition for procurements of materials required for pre-validation batch and validation batches, preparation of documents like feasibility reports /scale-up batch execution plan,pre-validation protocol, and BMR.Execution of scale-up batch at production area .compilation of the scale-up report. Submission of samples for analytical method validation.
- Validation/Registration batches: Preparation of documents like scale-up summary reports, Justification of specification, Cleaning assessment reports, risk assessment reports, a compilation of stability data, and stability protocol for initial for exhibit batches. Transfer the technology to the production unit through the execution of registration /Validation batches.
- Dossier Compilation: Preparation of product development reports for Module -3 compilation
- Revision of SOP for allocated equipment and maintenance of equipment.
Department: Formulation Research & Development
Qualification: M Pharma (Pharmaceutical)