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Computer Systems Validation Specialist

2 months ago


Montreal, Quebec, Canada Pharmascience Full time
Computer Systems Validation Specialist

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. Our work environment is stimulating, based on trust, cooperation, and going the extra mile.

Key Responsibilities
  • Develop and coordinate IT Computerized GxP System Validation and Infrastructure Qualification deliverables
  • Perform Impact and Risk Assessments for Computerized Systems (GAMP 5)
  • Develop, review, and coordinate validation documentation: Validation Plan, URS, Specifications, IQ/OQ/PQ/Data Migration/Cut-over Protocols, Trace Matrix, Validation Summary Reports, etc...
  • Provide guidance and recommend validation strategy, approaches, and testing to IT and Project Teams
  • Participate in 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
  • Provide training of IT Computer System Validation procedures and FDA CFR 21 Part 11 to Project Teams
  • Participate in IT Supplier Evaluation and Qualification of vendors
  • Participate in internal and external audits ensuring IT is compliant to regulatory expectations, PMS internal policies, and procedures
  • Develop IT SOPs and training material
  • Recommend improvements to validation and qualification processes
  • Maintain knowledge of current GMP, Quality, and Compliance policies and industry good practices for Quality Systems into IT Department
Requirements
  • 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