Quality Assurance Specialist
10 hours ago
Bausch Health Canada is a leading international pharmaceutical company dedicated to delivering high-quality health and wellness products to Canadians.
Our team manufactures and markets a wide range of pharmaceutical and health products distributed across the country. We invest in our employees and prioritize performance, innovation, and effective solutions to meet current needs.
Job SummaryThe Quality Assurance Specialist will design and deliver documentation for IT systems to meet pharma-related legal requirements. This role involves developing validation strategies, documentation, and ensuring compliance during configuration, implementation, testing, and maintenance of validated systems.
Key Responsibilities- Provide validation services for IT solutions, including determining the scope of validation and required documentation, approval and administration of validation documentation, and performing functional analysis and risk assessment.
- Contribute to change management activities, including checking the impact of changes on the system state, determining the impact of the computer system on the GxP process, and ensuring compliance with the change request form.
- Carry out the qualification of IT suppliers and ensure compliance with internal policies and procedures as well as external regulations.
- Collaborate with external service providers managing system changes and/or managing validation activities.
- Support internal and external audits of IT systems and applications.
- Experience with IT systems validation, GAMP 5, Annexes 11 and 15 of the EU GMP, and FDA Part.
- Knowledge of IT technologies related to production and distribution processes in the pharmaceutical industry.
- Excellent communication and project coordination skills.
- Ability to work in a dispersed team and self-motivated.
- Fluent in French and English.
Bausch Health is committed to equal employment opportunity and complies with equal employment opportunity laws in effect wherever it operates.
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