I.T. Systems Validation Expert

Mpi Inc.; Toronto; On-site; CAD 80,000 - 110,000; Full time

Job summary

A leading company in the validation sector is seeking a qualified individual to develop project validation plans and assist in driving project lifecycle phases. The ideal candidate will possess a Bachelor's degree and a minimum of 5 years of experience in computer systems validation, demonstrating strong familiarity with industry standards and tools. This role involves evaluating risk assessments and acting as a liaison between quality assurance and the project team, ensuring successful project delivery.

Qualifications

• Minimum 5 years experience in computer systems validation.
• Familiarity with cGMP, GLP, GAMP5, and GALP required.
• Experience with all phases of the systems development life cycle.

Responsibilities

• Develop project validation plans and generate summary reports.
• Evaluate risk assessment and functional requirements specifications.
• Act as liaison between quality assurance and project team.

Skills

Risk assessment

Project lifecycle management

Quality assurance

Education

Bachelor's degree in Business, IT, or comparable

Tools

SAP

LIMS

Empower

Job description

Develop project validation plans and generate summary reports.

1. Evaluate risk assessment and functional requirements specifications (FRS).

Act as liaison between quality assurance and project team.

Assist in driving each phase of the project lifecycle, including requirements gathering, risk assessment, and change/release management.

Qualifications:

• Bachelor's degree in Business, IT, or a comparable education & experience.
• Minimum of 5 years experience in computer systems validation, including authoring and executing IOQ/PQ protocols, with strong familiarity with cGMP, GLP, GAMP5, and GALP.
• Must be familiar with all phases of the systems development life cycle.
• Experience with SAP, LIMS, Empower is considered an asset.