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)
Keywords: job posting, IT Quality and Compliance, Fortrea, apprentice program, STEM, healthcare, clinical trials, computer science, life sciences jobs, Fortrea Apprentice Program for Lifescience
