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Quality Assurance Specialist
2 months ago
Bausch Health Canada is a leading international pharmaceutical company dedicated to bringing quality health and wellness products to Canadians. Our team manufactures and markets a wide range of pharmaceutical and health products distributed across the country.
Job SummaryWe are seeking a highly skilled Quality Systems Specialist to join our team. The successful candidate will design and deliver documentation for IT systems to fulfill pharma-related legal requirements. They will help develop validation strategies, documentation, and ensure compliance during configuration, implementation, testing, and maintenance of validated status consistent with quality policies and procedures.
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 in line with priorities and availability related to validation work, including checking whether the change does not affect the system state, determining the impact of the computer system on the GxP process, and ensuring compliance of the entire testing process.
- 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, and cooperate between departments in the areas of quality, IT, logistics, and production.
- Support internal and external audits of IT systems and applications, including being the primary point of contact for IT in all internal and external audit teams, identifying observations, and managing corrective actions.
- Experience with IT systems validation, deep knowledge and understanding of GAMP 5, Annexes 11 and 15 of the EU GMP, and FDA Part.
- Experience with validation and audits on GxP IT systems, knowledge of IT technologies related to production and distribution processes in the pharmaceutical industry.
- Excellent communication skills, ability to work at all levels, experience working with different cultures, project coordination skills, and a positive attitude.
- 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.
