IT Computer System Validation Specialist

Job title: IT Computer System Validation Specialist

Job description: Description :

Proud to be at the forefront of our industry since 1983, Pharmascience is a leader in generic medicines. We’re a Canadian company with global reach that has never lost sight of the human touch. The work environment we’ve chosen to maintain on a day-to-day basis is a stimulating one, based on trust, cooperation and continuous improvement. Join our team!

Pharmascience is currently looking for a IT Computer System Validation Specialist.

Tasks and responsabilities :

• Prepare and coordinate 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
• Ensure 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…)
• Ensure infrastructure components are qualified
• Ensure 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 and 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
• Bilingual in english and french (this position requires to collaborate with supplier outside the organisation)

Education : Bachelor

Experience : 0 years: Experience in GxP environment (preferable in the pharmaceutical industry) and knows about rules and regulations relating thereto.

5 years: Experience in IT computer system validation

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