Computer Systems, Validation Specialist
Pharmascience
- Montréal, QC
- Permanent
- Temps-plein
- 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
- 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
5 years: 5 to 10 years in computerized systems validation