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Executive - IVPT / IVRT

Executive - IVPT / IVRT

ConfidentialVadodara
12 days ago
Job description
  • Hands-on experience in conducting, planning, and monitoring In-vitro Skin Permeation Testing (IVPT) studies, including development, validation, pilot studies, and pivotal studies.
  • Thorough knowledge and complete understanding of FDA requirements for IVPT studies.
  • Expertise in data interpretation and day-to-day troubleshooting related to IVPT studies.
  • Experience in the review of raw data and the preparation of protocols and reports for development, validation, pilot, and pivotal IVPT studies.
  • Adherence to compliance and regulatory requirements for in-vitro studies.
  • Implementation and revision of Standard Operating Procedures (SOPs) related to IVPT studies.
  • Good subject knowledge related to Bio-analytical methods, Bio-sample analysis, and the interpretation of bioanalytical data.
  • Ensuring routine calibration and preventive maintenance of IVPT lab instruments are completed within timelines.
  • Experience in writing justifications and designing experiments to address Agency deficiencies related to IVPT.
  • Review and preparation of Module 5 documentation for IVPT.
  • Interaction with cross-functional teams to meet project timelines.

    • Skills Required

    IVPT, IVRT, Bioanalytical Methods, SOP Implementation, FDA Compliance, Module 5 Documentation

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