WFH/Remote Fortrea Apprentice Program for Lifescience – Apply Now!

Fortrea Apprentice Program for Lifescience in IT Quality and Compliance

Apprentice_IT Quality and Compliance

Remote type: Remote

Locations: 

• Bangalore
• Mumbai

Time type: Full time

Posted on: Posted 3 Days Ago

Job Requisition ID: 251041

Apprentice: IT Quality and Compliance Apprentice

Company Overview:

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in ~100 countries, Fortrea is transforming drug and device development for partners and patients across the globe

India Apprentice Program:

Exciting opportunity to be part of the Fortrea India Apprentice Program!

As a Fortrea Apprentice, you will have the opportunity to support meaningful assignments that compliment an education in STEM+ Business and Healthcare disciplines, and are inspiring and valuable in our mission to improve health and improve lives across the globe

Capitalize on a dedicated training and development program that will support your scientific and professional career aspirations and take pride in delivering work that helps save the lives of millions of people around the world.

About Team:

We are a multinational IT team that ensure that IT is compliant with and following applicable regulations for IT in a business managing clinical trials. The areas managed by IT Quality and Compliance includes

• Computer System Validation
• Customer/Sponsor Audit Support
• Regulated IT Document Management
• IT Learning Management
• Regulatory Questionnaires and Contract review

Apprenticeship Summary:

The Apprentice participates in and executes the entry level department functions (Designation of Apprentice) in accordance with Fortrea and/or sponsor Standard Operating Procedures (SOPs)

• Document Management and Organization
• Metrix on IT Quality
• Questionnaires and information requests
• Review and update of regulated system inventory
• Other duties as assigned

Education/Qualifications/Skills:

General knowledge of computer systems infrastructure, development, support and security
Nice to have knowledge of regulations on computerized systems in clinical trials

Education: Bachelor’s degree or equivalent in a field related to computer science or Life sciences.

Skills

• Computer System Validation
• FDA 21 CFR Part 11,” Electronic Records and Electronic Signatures; Final Rule” (Part 11)
• MHRA “GxP Data Integrity Guidance and Definitions” (MHRA)
• EudraLex Volume 4 Annex 11, “The Rules Governing Medicinal Products in the European Union” Computerised Systems (Annex 11)
• ISO27001, National Institute of Standards and Technology (NIST)

APPLY ONLINE HERE

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