Spécialiste, validation des systèmes informatiques

Proud to have been at the forefront of our industry since 1983, Pharmascience is a leader in generic drugs. We are a Canadian company with a global reach for whom the human touch is important.

The work environment we choose to maintain every day is stimulating : it's based on trust, cooperation and going the extra mile. Join our team!

The Computer Systems Validation Specialist guides the validation of Pharmascience's Computer systems.

Responsabilities & Duties

• Prepares and coordinates the development of IT Computerized GxP System Validation and Infrastructure Qualification deliverables
• Perform Impact and Risk Assessments for Computerized Systems (GAMP 5)
• Develops, reviews, coordinates and participates in the development of validation documentation : Validation Plan, URS, Specifications, IQ / OQ / PQ / Data Migration / Cut-over Protocols, Trace Matrix, Validation Summary Reports, etc
• Provides guidance and recommends validation strategy, approaches and testing to IT and Project Teams
• Participates in the System Periodic Reviews and System Retirement
• Ensures new and existing implemented IT Computerized GxP Systems are validated and compliant with all applicable regulations (Health Canada, US FDA CFR Part 11, EU Annex 11, etc )
• Ensures infrastructure components are qualified
• Ensures IT Change Controls are assessed for impact, resolution is documented, tested and approved to maintain the systems validated state
• Provides training of IT Computer System Validation procedures and FDA CFR 21 Part 11 to Project Teams
• Participates in the IT Supplier Evaluation and Qualification of vendors
• Participates in internal and external audits ensuring IT is compliant to regulatory expectations, PMS internal policies and procedures
• Develops IT SOPs and training material
• Recommends improvements to validation and qualification processes
• Maintains knowledge of current GMP, Quality and Compliance policies and industry good practices for Quality Systems into IT Department

Skills, Knowledge & Abilities

• Knowledgeable of Health Canada, GAMP 5, CFR 21 Part 11, and current Good Manufacturing Practices.
• Able to execute validation strategy on the activities surrounding the implementation of IT Computerized Systems.
• Able to analyze requirements, assess risk and determine the degree of compliance evidence necessary to satisfy compliance requirements.
• Good planning, prioritization, analysis aptitudes and able to manage simultaneous project rollouts
• Good communication skills
• Good judgment in degree of compliance and risk
• Good organization, problem-solving and decision-making skills
30+ days ago