Executive - IVPT/IVRT

Alembic Pharmaceuticals

3 - 8 years

3 - 8 Lacs

vadodara gujarat india

Posted:1 week ago| Platform: Foundit logo

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Skills Required

ivpt ivrt bioanalytical methods sop implementation fda compliance module 5 documentation

Work Mode

On-site

Job Type

Full Time

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.

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