Regulatory Compliance Specialist
5 days ago
As a Regulatory Compliance Specialist at Tata Consultancy Services, you will play a critical role in ensuring the regulatory compliance of our pharmaceutical products. This includes maintaining compliant specifications and standards, as well as managing changes to those standards.
Key Responsibilities- Assess the impact of GMP quality requirements and regulatory filing on our products, 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 and marketing authorization.
- Authorize the release of inventory in the SAP system, ensuring accurate quantities, material status, and expiration dates.
- Build and maintain relationships with supply sites, wholesalers, and key internal partners.
- Pharmaceutical Quality Control/Quality Systems knowledge and experience.
- Understanding of pharmaceutical production processes, including manufacturing, packaging, and testing.
- Awareness of Post NOC changes.
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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