Validation Analyst
Posted on Mar 19, 2024VALIDATION ANALYSTS, Job
Code 1104:
ITVorks Inc., seeks Validation
Analysts for its Princeton, NJ office to Review documents including clinical
study reports, labeling drafts and validation and stability protocols and
reports. Develop and Execute Installation, Operational, and Performance
Qualification (IQ, OQ and PQ) protocols, and prepare Test Plan and Final Validation
Report. Perform GAP analysis on GXP system that directly affects product
quality and Data Integrity and ensure all the requirements have been tested and
also comply with applicable FDA Regulations. Prepare validation or performance
qualification protocols for new or modified manufacturing processes, systems,
or equipment for pharmaceutical production. Prepare and submit of Chemistry,
Manufacturing, and Controls (CMC) sections for regulatory drugs and
submissions, information amendments, supplements, and annual reports. Travel to
various unanticipated locations in the United States to interact with clients
for short or long term assignments. Master’s Degree or foreign equivalent in
Pharmacy/Regulatory Affairs/Chemistry or related + 1 yr of experience as
Clinical Analyst, Regulatory Affairs Associate, QA Engineer or related,
developing/creating Test Plan, and using software validation life cycle and EDC
applications (Medrio, RAVE and Inform) is required. Work Location: Princeton, NJ. Travel required to interact with clients & train end users.
Please
send resume & cover letter indicating position and Job Code to hr@itvorks.com. Human Resources, ITVorks Inc., 101
College Rd East, Suite #302, Princeton, NJ 08540.
iTvorks, Inc.
careers@iTvorks.com