Product Compliance Specialist for Regulatory Affairs
6 days ago
Tata Consultancy Services is a global leader in IT services, consulting, and business solutions. We are committed to delivering exceptional results to our clients through our unique Location Independent Agile delivery model.
We are seeking an experienced Product Compliance Specialist to join our team in regulatory affairs. In this role, you will be responsible for ensuring the timely and compliant release of products to the Canadian market.
Key Responsibilities:
- Ensure regulatory compliance of all JI products through maintaining compliant specifications/standards (RSSs) and manages change to those standards
- Assess the impact on GMP quality requirements and regulatory filing (e.g., 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
To succeed in this role, you will need a strong understanding of pharmaceutical production processes, including manufacturing, packaging, and testing. You will also have excellent communication skills and be able to work collaboratively with internal stakeholders to establish priorities and develop systems/processes to support product compliance activities.
This is an exciting opportunity to join a dynamic team and contribute to the success of our company. If you are a motivated and detail-oriented individual with a passion for regulatory affairs, we encourage you to apply.
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