Compliance Specialist

1 month ago

Toronto, Ontario, Canada Tata Consultancy Services Full time
About the Role

Tata Consultancy Services is an equal opportunity employer, embracing diversity in all its forms to create a workforce that reflects the societies we operate in. Our commitment to culture and diversity is evident in our people stories across the workforce, implemented through equitable workplace policies and processes.

We are a leading IT services, consulting, and business solutions organization, partnering with many of the world's largest businesses in their transformation journeys for over 55 years. Our consulting-led, cognitive-powered portfolio of business, technology, and engineering services and solutions is delivered through our unique Location Independent Agile delivery model, recognized as a benchmark of excellence in software development.

A part of the Tata group, India's largest multinational business group, we have over 615,000 of the world's best-trained consultants in 55 countries. Our proactive stance on climate change and award-winning work with communities across the world have earned us a place in leading sustainability indices such as the MSCI Global Sustainability Index and the FTSE4Good Emerging Index.

Key Responsibilities
  • Maintain compliant specifications/standards (RSSs) and manage changes to those standards to ensure regulatory compliance of all JI products.
  • Assess the impact on GMP quality requirements and regulatory filing, including changes to test methods, manufacturing, and packaging.
  • Ensure ongoing product compliance to Canadian Regulations and J&J Quality requirements through review and evaluation of Supplier Release Documentation and Executed Batch Reviews.
  • Review and assess analytical, manufacturing, and packaging documentation for finished products to ensure compliance with requirements/marketing authorization and recommend product disposition (approve/reject).
  • Authorize the release of inventory in the SAP system, ensuring accurate quantities, material status, and expiration date.
  • Build and maintain relationships with supply sites, wholesalers, and key internal partners.
  • Partner/collaborate with key business partners to establish priorities, develop, and manage systems/processes to support product compliance activities (Product release, Executed Batch records, inventory management, unique identifier, retain sample program).
  • Participate in other quality projects as required.
Requirements
  • Awareness of Post NOC changes.
  • Pharmaceutical Quality Control/Quality Systems.
  • Understanding of pharmaceutical production processes i.e. manufacturing, packaging, and testing.
What We Offer

Tata Consultancy Services Canada Inc. is committed to meeting the accessibility needs of all individuals in accordance with the Accessibility for Ontarians with Disabilities Act (AODA) and the Ontario Human Rights Code (OHRC). The estimated salary for this role is $90,000 per year.

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