Computer Systems, Validation Specialist
3 weeks ago
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.
Responsibilities & Duties- Prepares and coordinates the development of IT Computerized GxP System Validation and Infrastructure Qualification deliverables.
- Performs 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.
Bachelor's degree.
Experience0 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.
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