RxCloud

Computer Systems Validation Lead

RxCloud  •  San Francisco, CA (Onsite)  •  8 days ago
Apply
AI can make mistakes so check important info. Chat history is never stored.
28
AI Success™

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.
RxCloud

About RxCloud

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.

Industry
Chemicals & Materials
Company Size
11-50 employees
Headquarters
Pleasanton, California
Year Founded
2020
Social Media