Computer Systems Validation Specialist
2 months ago
About Pharmascience
Pharmascience is a Canadian company with a global presence and a history in the pharmaceutical industry since 1983. We specialize in generic drugs and value the human touch, offering a stimulating work environment based on trust, cooperation, and dedication to going the extra mile.
About the Role
The Computer Systems Validation Specialist plays a crucial role in overseeing the validation of Pharmascience's computer systems. This position ensures compliance with relevant regulations such as Health Canada, US FDA CFR Part 11, and EU Annex 11.
Responsibilities & Duties:- Develop and coordinate Computerized GxP System Validation and Infrastructure Qualification deliverables
- Conduct Impact and Risk Assessments for Computerized Systems according to GAMP 5 standards
- Create, review, and participate in the development of validation documentation including Validation Plans, User Requirements Specifications (URS), Specifications, Protocols, Trace Matrices, and Validation Summary Reports
- Provide guidance on validation strategy, approaches, and testing to IT and Project Teams
- Participate in System Periodic Reviews and System Retirement processes
- Ensure compliance of new and existing IT Computerized GxP Systems with relevant regulations such as Health Canada, US FDA CFR Part 11, EU Annex 11, etc.
- Qualify infrastructure components and assess IT Change Controls for maintaining systems validation
- Conduct training on IT Computer System Validation procedures and FDA CFR 21 Part 11
- Participate in IT Supplier Evaluation and vendor qualification
- Contribute to internal and external audits to ensure IT compliance with regulatory expectations and internal policies
- Develop IT Standard Operating Procedures (SOPs), training materials, and recommend process improvements
- Maintain updated knowledge of GMP, Quality, and Compliance policies and practices within the IT Department
- Familiarity with Health Canada, GAMP 5, CFR 21 Part 11, and Good Manufacturing Practices
- Ability to implement validation strategies for IT Computerized Systems
- Analytical skills to assess requirements and determine compliance levels
- Strong planning, prioritization, and analysis abilities for managing multiple project rollouts
- Effective communication, judgment, organization, problem-solving, and decision-making skills
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