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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 aComputer 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
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.