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Computer System Validation Expert

Infinite Outsourcing Solutions

This is a Full-time position in Toronto, ON posted September 6, 2017.

IOS Description

Infinite Outsourcing Solutions is a top provider to excellent service in the recruiting and staffing industry. With nearly 17 years of combined experience in the recruiting and staffing industry, we have developed the knowledge and skills to deliver the perfect fit between a candidate and a client.

We are seeking a highly motivated and energetic individual to join our IOS team as a Computer System Validation Expert for our client, who is a leader in the growing and highly innovative vaccines industry.

PROJECT DESCRIPTION

This project includes the participation in Quality Operations, Quality Validation Systems and activities supporting the ITS systems, including:

  • ITS Change Management process and tool support
  • ITS Document Management process and tool support
  • Participation and lead Computerized Validation support for ITS projects
  • Interface with ITS Department members, and business system owners and users for project and tool support
  • Multiple small projects in ITS that will require Quality and or Computerized System Validation support.

In addition, other deliverables include, but are not limited to:

PUMA Project Methodology : the contractor will need to provide input to or author documents according to the company’s PUMA project methodology.

Computerized System Validation: the contractor will provide supports on the strategy and execution of computerized system validation activities. This system will be used as the standard for all computerized system validation work and will be supported by the established templates provided by the company. The contractor will ensure that the validation packages are in a review ready state and will provide feedback, corrections, or changes as necessary in order to complete the validation activities.

Testing: the contractor may participate in testing of the changes to the system by reviewing pre and post execution test scripts with the help of the ITS personnel or business users. These test scripts will be developed in document management system and reviewed and approved through the document workflow process.

JOB DESCRIPTION

  • Participation in ITS project for Computerized System Validation support: – Follow established CSV methodology – Perform System Criticality Assessment for assigned projects – Develop and implement validation strategy for projects – Conduct functional risk assessments – Complete or support CSV templates and deliverables for assigned projects – Ensure complete review and approval of validation deliverables
  • ITS Change Management process and tool support: – Review and approval – Test script review
  • ITS Document Management process and tool support: – Provide support to ITS department on the ITS document management tool for specific projects
  • Interface with ITS Department members for project and tool support
  • Multiple small projects in ITS that will require Quality and or Computerized System Validation support.

JOB REQUIREMENTS

The candidate must possess the following skills:

  • Bachelors degree: Computer Science or Business/Sciences or Engineering with computer science concentration.
  • Minimum 3 – 5 years work experience.
  • Understanding of GxP regulations and Computerized System Validation principalsUnderstanding of Document Management principalsDemonstrated technical writing and oral communication skills.Preferred: scientific education or experience, with validation strategy and test script design, technical document reviews, and strong interpersonal skills. Understanding and with validation experience on SAP is a valuable asset.

Skills Required

  • Education level: College
  • Work experience (years): 3-5 years

Package

Salary: N/D

How to Apply

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