Quality Systems Specialist

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 (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,

Checking whether the change does not affect the system state,

Cooperation in the implementation of the CSV framework and the validation process based on GAMP 5 (Good Automated Manufacturing Practice),

Primary point of contact for IT in all internal and external audit teams where an IT inquiry is required,

EXPERIENCE AND SKILL SETS PREFERRED

The ideal candidate is well-experienced with IT systems validation, with deep knowledge and understanding of the following areas :

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.