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Senior Research Associate

6.00 to 8.00 Years   Ahmedabad   03 Jul, 2021
Job LocationAhmedabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryManufacturing
Functional AreaBio Tech / R&D / Scientist
EmploymentTypeFull-time

Job Description

*

  • Execution of NCE projects, platform development projects using QbD principle.
  • Formulation development, process development, and manufacturing of GMP batches to the assigned product.
  • Basic technical understanding about work done, rationale etc.
  • Understanding about process selection and formulation (excipient) selection
  • Knowledge about API Properties, preformation aspect
  • Basic understanding about the process Roller compaction, wet granulation, compression, coating and equipments for the same
  • Basic understanding about in process testing and instrument used for same (Blend flow properties, tablet characteristic)
  • Blend uniformity and content uniformity testing and acceptance criteria
  • Understanding on BCS classification
  • Understanding about dissolution basic and impurity
  • Preparation of literature summary and development report.
  • Follow GxP (GMP, GDP etc.) for all processes
  • Preparation of technical documents like MFC, BMR, BPR, and Stability protocol etc. following the GDP.
  • Execution of development and scale up/clinical batches in pilot plant under GMP condition.
  • Performing calibration and maintenance of R&D instruments.
  • Procuring/ indenting materials and machines change parts related to concern projects.
  • Maintain safe and hygienic condition in respective department.
  • Ensuring the use of personal protective equipment during batch execution.
, *
  • Execution of NCE projects, platform development projects using QbD principle.
  • Formulation development, process development, and manufacturing of GMP batches to the assigned product.
  • Basic technical understanding about work done, rationale etc.
  • Understanding about process selection and formulation (excipient) selection
  • Knowledge about API Properties, preformation aspect
  • Basic understanding about the process Roller compaction, wet granulation, compression, coating and equipments for the same
  • Basic understanding about in process testing and instrument used for same (Blend flow properties, tablet characteristic)
  • Blend uniformity and content uniformity testing and acceptance criteria
  • Understanding on BCS classification
  • Understanding about dissolution basic and impurity
  • Preparation of literature summary and development report.
  • Follow GxP (GMP, GDP etc.) for all processes
  • Preparation of technical documents like MFC, BMR, BPR, and Stability protocol etc. following the GDP.
  • Execution of development and scale up/clinical batches in pilot plant under GMP condition.
  • Performing calibration and maintenance of R&D instruments.
  • Procuring/ indenting materials and machines change parts related to concern projects.
  • Maintain safe and hygienic condition in respective department.
  • Ensuring the use of personal protective equipment during batch execution.

Keyskills :
researchvalidationhplcnmrliteratureroller compactionprocess developmentposition managementdevelopment projectsplatform developmentstability protocolapimfcgmpgxpbprbmrbcs

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