Formulation And Development ROW DM OSD Nagpur Plant

1 week ago

Nagpur, Maharashtra, India Select Source International Full time ₹ 20,00,000 - ₹ 25,00,000 per year

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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