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Quality Systems Specialist
3 months ago
Bausch Health Canada is the international head office of Bausch Health Companies, one of the fastest growing international pharmaceutical companies dedicated to bringing quality health and wellness products to all Canadians.
Our team manufactures and markets a wide variety of pharmaceutical and health products that are distributed in pharmacies, healthcare practices and hospitals across the country.
At Bausch Health, we invest in our employees and we believe in the importance of cultivating performance and outdoing ourselves in finding new and better solutions with the aim of responding innovatively and effectively to current needs.
IT Specialist Quality Sytems (Validation & Compliance)
The IT Specialist Quality Sytems will design and deliver documentation for IT systems to fulfill pharma related legal requirements.
The successful candidate will help develop validation strategies, documentation, and ensure compliance during configuration, implementation, testing and maintain validated status that are consistent with quality policies and procedures.
This position is closely aligned with the Global Validation leadership and contributes to educate and deploy common practices across the regions. As a complementary activity, contribution to change management activities according to priorities and availability related to required validation work.
SCOPE AND CORE RESPONSIBILITIES
Providing validation services for IT solutions:
Determining the scope of validation and required documentation,
Approval and administration of validation documentation, including: SOPs, acceptance criteria, plans and reports required for validated systems. Confirmation the correctness and suitability of the validation documentation listed in the change request form,
Performing functional analysis and risk assessment.
Contribution to change management activities in line with priorities and availability related to validation work:
Checking whether the change does not affect the system state,
Determines the impact of the computer system on the GxP process and making a preliminary risk assessment for the computer system,
Ensuring compliance of the entire testing process, including the description of the development and testing environment, with the change request form,
Release the change in test and production environments, performing a final review before closing the change.
Carrying out the qualification of IT suppliers
Ensuring compliance with internal policies and procedures as well as external regulations:
Cooperation in the implementation of the CSV framework and the validation process based on GAMP 5 (Good Automated Manufacturing Practice),
Development and training interested business and IT team members on IT validation procedures, in line with the global validation direction,
Ensuring consistency of validation processes across regions in close collaboration with Corporate IT Validation leadership.
Collaboration with external service providers managing system changes and/or managing validation activities.
Cooperation between departments in the areas of quality, IT, logistics and production.
Support for internal and external audits of IT systems and applications:
Primary point of contact for IT in all internal and external audit teams where an IT inquiry is required,
Identification of observations and management of corrective actions,
Collaboration with management and business to implement solutions,
Deviation tracking for GxP systems, defining CAPA.
EXPERIENCE AND SKILL SETS PREFERRED
The ideal candidate is well-experienced with IT systems validation, with deep knowledge and understanding of the following areas:
Educated on GAMP 5, Annexes 11 and 15 of the EU GMP and FDA Part 11.
Experienced on validation and audits on GxP IT systems.
Knowledge of IT technologies related to production and distribution processes in the pharmaceutical industry.
Excellent communicator with the ability to work at all levels.
Experience working with different cultures.
Positive attitude and longing for results are essential qualities.
Analytical and creative, able to offer new ideas and perspectives to the situation.
Flexible approach to working hours and location.
Ability to work as part of a dispersed team but also self-motivated.
Broad experience of IT solution.
Ability to perform and conduct workshops and meetings to develop solutions.
Fluent in French and English.
The masculine is used in this publication without prejudice for the sake of conciseness.
Bausch Health is committed to equal employment opportunity and complies with equal employment opportunity laws in effect wherever it operates.
Bausch Health is an EEO/AA employer M/F/D/V.
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