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Senior Principal Scientist

5.00 to 7.00 Years   Ahmedabad   24 Sep, 2021
Piramal Glass
Job LocationAhmedabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryManufacturing
Functional AreaBio Tech / R&D / Scientist
EmploymentTypeFull-time

Job Description

  • Ensure method development, Validation and Technology transfer of different analytical method to manufacturing or client site.
Support to Lab and Clinical stability of formulation product.
  • Provide project progress update to client via teleconference or email communication. To ensure the compliance in the lab.
Analytical method development of NCEs and formulations (Tablets, Capsules,Liquid solution, Suspensions & Liposomes) using QbD approach
  • Physico-Chemical Characterization of different NCEs (Solubility, pKa, Log P, Log D)
  • Regulatory compliance / on site audit related activities.
  • Perform internal audit of cross functional department as per QA schedule and share the finding with team
  • Ensuring GxP in all levels of analytical works.
Review of validation specification, standard test procedure, protocol and report. Custom field creation, qualification, SOP review and tfaining to all team members
  • Ensure Qualification of analytical instruments as per CSV sop.
  • Review of all SOP, Guideline and qualification documents.
  • Preparing the OPEX and CAPEX budget for department.
  • Ensure Data integrity.
, *M.Pharm/M.Sc/Ph.D.

Keyskills :
apichemical analysisdmffilingcontinuous improvement facilitationon siteinternal auditmethod developmenttechnology transferanalytical instrumentsgxpsopopexemailcapexclinicalfda

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