Apprentice it Quality and Compliance

2 days ago

Bengaluru Karnataka, India Fortrea Full time

**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)_**

Learn more about our EEO & Accommodations request here.

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