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Full Service Computer Support Since 2006 Call Today

Certified Computer Systems Validation Specialist

Next Generation Computer Support. Our core understandings...

 

  • Subject matter experts on all product development related design control SOP’s.
  • BDR experts in Reviving a Computer System and Data Restoration.
  • IT Bridging when no one else can perform. We CAN & WILL.
  • Matured experience in developing SDLC Plans of Action.
  • We understand business, technical, and operational requirements for Software as a Service and work with technical and product leaders to create plans consistent with quality compliance & systems control.
  • We act as a bridge between cross functional team members and quality compliance. Identifying gaps and helping resolve questions and open issues.
  • Authoring, reviewing, finalizing verification and validation deliverables including Plan, Requirements, Test Plan, Design, Protocols, Traceability Matrix, Reports and Standard Operating Procedures (SOPs).
  • Managing and updating requirements in various tools
  • Develop JIRA
  • Develop ITIL
  • Tests HP ALM
  • Sharepoint and Projects Expert
  • Collaborate with across functions and departments (e.g. Legal, Engineering, Architecture, Product Management, PMO, Risk Management, Internal Audit, Quality)

Our Qualifications Include

  • BS/BA/MS or equivalent with 10+ years experience.
  • Validation specialist experience & product test experience in auto manufacturing. bio-pharmaceutical, aerospace and utility.
  • Excellent written and verbal communication skills; Ability to produce high quality Standard Operating Procedures (SOP’s) and product development plans, requirements and reports
  • High attention to detail
  • We have the ability to take ownership and be effective with limited supervision leading your team.
  • Effective at engaging with teams in various functions and across different levels.
  • We have Strong organizational skills and ability to prioritize and manage multiple activities simultaneously with passion and care.

Our Work Experience Includes:

  • Experience in authoring, reviewing and approving of all verification and validation deliverables including Plan, Requirements, Test Plan, Design, Protocols, Traceability Matrix, Reports and Standard Operating Procedures (SOPs).
  • Working in compliance with the Quality Management System
  • Experience in supporting product development
  • Knowledgeable in Quality System Regulations, Medical Device Directive, ISO13485 Quality Standards, and 21 CFR Part 11, 820.
  • Experience in quality management systems and medical device product development processes.
  • An understanding of SaaS, DrasS, PasS and software development.
  • Highly Advanced Hardware and Software Consulting