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Analytical Method Validation ( Injectable )

3.00 to 8.00 Years   Indore   19 Apr, 2021
NMS Consultant Hiring For Leading Pharma Company
Job LocationIndore
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaBio Tech / R&D / Scientist
EmploymentTypeFull-time

Job Description

To perform analytical method validation / Verification / Method transferfor drug substances and injectable drug products within given timelines.

  • To prepare the analytical method validation protocols / reports.
  • To troubleshoot the analytical method validation and transfer issues.
  • To support USFDA deficiency related activities
  • Observance of the laid down standard operating procedure (SOP) as applicable at the all formulation sites (Labs, production facilities etc.), including laboratory safety.
  • To prepare method validation / verification and method transfer protocols & reports for API, RM and finished product. 10
  • To support the analytical method transfer from ARD lab to respective manufacturing unit/ pilot plant with required documentation from experience Team Member
To support analytical query related activities.Desired Candidate Profile Analytical Method Validation, Transfer and regulatory knowledge FDA regulations and guidances GLP Expertise in HPLC, UPLC, Dissolution Testing by I,II and IV, Titrimetric Techniques,TLC, GC, IC, AAS, UV-Visible Spectrophotometer, Mastersizer and Zeta sizer. Good communication Stake holder management Work in transparent environment Proactive Innovative

Keyskills :
pilot plantglpuv-visible spectrophotometermethod validationdissolution testinghplctlcanalytical method validationuplcmethod transferusfdaproduction facilitiescontinuous improvement facilitationstakeholder managementapistandard operati

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