Product Compliance Specialist

1 week ago


Toronto, Ontario, Canada Tata Consultancy Services Full time
Job Overview

Tata Consultancy Services is a leading IT services, consulting, and business solutions organization with over 55 years of experience in partnering with top businesses globally.

About the Role

We are seeking a Product Compliance Specialist to ensure regulatory compliance of all JI products through maintaining compliant specifications/standards (RSSs) and managing change to those standards.

Key Responsibilities:
  • Assess the impact on GMP quality requirements and regulatory filing (e.g. changes to test methods, manufacturing and packaging).
  • Evaluate Supplier Release Documentation and Executed Batch Reviews for ongoing product compliance to Canadian Regulations and J&J Quality requirements.
  • 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.
  • Built relationships with supply sites, wholesalers, and key internal partners.
  • Partnered/collaborated with key business partners to establish priorities, develop and manage systems/processes to support product compliance activities.
Requirements
  • Pharmaceutical Quality Control/Quality Systems knowledge.
  • Understanding of pharmaceutical production processes i.e. manufacturing, packaging, and testing.
  • Awareness of Post NOC changes.
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).



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