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Computer Systems Validation Lead

Role overview

Qualifications

  • At least 10 years of experience in computer systems validation activities
  • At least 7 years of experience in GMP/GxP regulated environments
  • Proven experience developing validation documentation and testing protocols
  • Experience with FDA 21 CFR Part 11

Responsibilities

  • Support and perform all aspects of computer systems validation activities
  • Develop scalable validation strategies and documents
  • Perform document reviews
  • Demonstrate continuous compliance

About the company

RxCloud logo

RxCloud

RegTech (Regulatory & Compliance Technology)

RxCloud is a professional services organization focused exclusively on Pharma, Biotech and Medical device industries. We are a full-scale Quality Assurance Organization driving innovation & ensuring compliance across the industry. Our mission is to deliver Quality, Compliance, Innovation, Customer Experience, and speed that enables global Life Science industry to continuously innovate and significantly reduce drug development life cycle. We are specialized in providing the CSV services, GxP Audits (GMP, GDP, GLP, GCP, GVP) as a service, Veeva Services, Software Quality Assurance services. Our full spectrum of service offerings includes QMS Consulting, End to End Global Audit Management, CAPA management, SOP Authoring, QA as a service. RxCloud’s differentiation is bringing in speed and agility to achieve compliance first time and every time.

Company details

Company typeStartup
IndustryRegTech (Regulatory & Compliance Technology)
Company size11 - 50

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Job description

  • At least 10 years of experience supporting and/or performing all aspects of computer systems validation activities including development of scalable validation strategies, documents, and perform document reviews
  • At least 7 years prior experience in computer systems validation within GMP/GxP regulated environments
  • Proven experience developing full validation documentation and testing protocols within the various SDLC phases that is scalable and maintainable to demonstrate continuous compliance
  • Experience with FDA 21 CFR Part 11
  • Experience with the validation of Enterprise systems SAP and/or MES system Preferred. Validation of Life sciences systems such as Veeva, Trackwise, Argus, Clnical, Quality systems highly desired. 
  • Broad understanding of the test management Tools, including experience and knowledge Microfocus ALM, ValGenesys etc preferred.
  • Knowledge and experience around CSA highly preferred. 


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MR

Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
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