Computer Systems, Validation Specialist

Pharmascience

  • Montréal, QC
  • Permanent
  • Temps-plein
  • Il y a 1 mois
Description :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
Education : BachelorExperience : 0 years: Experience in a GxP environment (preferably in the pharmaceutical industry) and knowledge of related rules and regulations.
5 years: 5 to 10 years in computerized systems validation

Pharmascience