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Computer System Validation Expert
3 months ago
Are you passionate about enhancing patient outcomes? At CB Canada, we foster a progressive and collaborative environment focused on patient care and dedicated to improving health outcomes. Our organization is committed to creating healthier futures.
Key Responsibilities:
PRIMARY DUTIES:
- Lead the implementation of computer system validation (CSV) strategies, ensuring that all computerized systems (both hardware and software) meet GxP compliance, particularly adhering to regulatory standards.
- Develop and review validation strategies and documentation in alignment with our CSV Policy and Procedures, ensuring compliance with business requirements.
- Prepare comprehensive validation documentation packages, including the creation and execution of various validation and qualification documents such as Validation Plans, Risk Assessments, and Testing Protocols.
- Assess changes in validated systems using a risk-based methodology, determining appropriate validation requirements.
- Manage validation projects effectively, ensuring timely completion and alignment with QA timelines.
- Design and execute test cases tailored to the risks associated with applications and enhancements.
- Provide support and guidance to team members in developing validation deliverables, including User Requirements Specifications and Functional Requirements Specifications.
- Review Unit Test documentation from IT teams to ensure thorough testing prior to validation activities.
- Oversee defect management in validation projects, organizing meetings to address and resolve identified issues.
- Maintain and archive validation documentation for easy retrieval and compliance.
- Collaborate with IT and QA to train team members on validation practices and tools.
- Conduct audits of IT and validation processes as scheduled.
- Stay updated with industry and regulatory guidelines to ensure compliance.
- Manage third-party vendor activities related to software validation.
- Adhere to all relevant policies and safety regulations.
- Flexibility to work additional hours as needed.
Qualifications:
EXPERIENCE AND EDUCATIONAL BACKGROUND:
A minimum of three years of hands-on experience in the validation of GxP computerized systems, preferably within the pharmaceutical or biotech sectors. A degree in computer sciences or a related field is required.
SKILLS AND KNOWLEDGE:
- Formal training in computer sciences or related fields.
- Comprehensive understanding of computer system validation processes and regulatory requirements.
- Strong communication skills, both verbal and written.
- Experience in quality assurance principles and practices.
- Proven teamwork and interpersonal skills.
- Excellent organizational skills with attention to detail.
- Ability to prioritize tasks and meet deadlines.
- Familiarity with project management principles.
What CB Canada Offers:
We provide competitive compensation and a comprehensive benefits package designed to meet the diverse needs of our associates.
Schedule:
Full-time
Equal Employment Opportunity:
CB Canada is committed to providing equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status, or any other protected class.
Accessibility Policy:
CB Canada is dedicated to fair and accessible employment practices and will accommodate individuals with disabilities during the recruitment and employment processes.
