Regulatory Compliance Specialist
6 days ago
Tata Consultancy Services, a leading IT services company, is seeking a highly skilled Regulatory Compliance Specialist to join our team.
About Us:
TCS is an equal opportunity employer that values diversity and inclusivity. Our commitment to culture and diversity is reflected in our people stories across our workforce, implemented through equitable workplace policies and processes.
We are a part of the Tata group, India's largest multinational business group, with over 615,000 of the world's best-trained consultants in 55 countries. We have been partnering with many of the world's largest businesses in their transformation journeys for over 55 years.
About the Role:
This role involves ensuring regulatory compliance of all JI products through maintaining compliant specifications/standards (RSSs) and managing change to those standards. This includes assessing the impact on GMP quality requirements and regulatory filing (e.g., changes to test methods, manufacturing and packaging).
The successful candidate will be responsible for ensuring ongoing product compliance to Canadian Regulations and J&J Quality requirements through review and evaluation of Supplier Release Documentation and Executed Batch Reviews. They will also review and assess analytical, manufacturing, and packaging documentation for finished products to ensure compliance with requirements/marketing authorization to recommend product disposition (approve/reject).
In addition, this role involves authorizing the release of inventory in the SAP system ensuring accurate quantities, material status, and expiration date. The ideal candidate will build and maintain relationships with supply sites, wholesalers, and key internal partners. They will 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).
Salary: $80,000 - $110,000 per annum, depending on experience.
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