
Formulation And Development ROW DM OSD Nagpur Plant
4 weeks ago
Planning and coordinating with project management team, regulatory affairs, analytical development and management team
- Pivotal involvement in product pre-formulation study and prototype formulation development
- Preparing reports, compiling/interpreting data and validating stability data of developmental batches
- Key role involvement in a vast gamut of activities encompassing - formula & process optimization, monitoring scale-up batches, validating batches for regulatory markets; adhering to regulatory markets like ROW standards and so on
- Responsible for executing site transfer projects from contracts like Bells, Teva, Relonchem and Nova
- Involved in evaluating Critical Quality Attribute (CQA) & Critical Process Parameter (CPP) of the product during technology transfer while in a process challenge study
- Preparing a wide range of reports such as Interim Pre-formulation summary reports, formulation development reports and product development reports as per exhibit batch records
- Instrumental in Master Formula Record (MFR), Process Validation Protocol (PVP), Batch Manufacturing Record (BMR), Hold Time Study Protocols, Sampling Protocols, Compatibility Study Protocols and Stability Protocols
- Executing DOE (Stat-Ease) trials by QBD concept and designing the process as given
- Extensively preparing and reviewing Batch Production Control Records (BPCR) for ANDA submission & commercial purposes
if interested mail cv at :-
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Nagpur, Maharashtra, India Select Source International Full time ₹ 20,00,000 - ₹ 25,00,000 per yearPlanning and coordinating with project management team, regulatory affairs, analytical development and management teamPivotal involvement in product pre-formulation study and prototype formulation developmentPreparing reports, compiling/interpreting data and validating stability data of developmental batchesKey role involvement in a vast gamut of activities...
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