Regulatory Compliance Specialist for Pharmaceutical Products
6 days ago
Tata Consultancy Services (TCS) is a global leader in IT services and consulting. We are seeking an experienced Regulatory Compliance Specialist to join our team.
Key Responsibilities:
- Review and assess analytical, manufacturing, and packaging documentation for finished products to ensure compliance with marketing authorization requirements.
- Evaluate changes to master production documentation to ensure alignment with marketing authorization.
- 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 with business stakeholders to establish priorities and develop systems/processes to support product compliance activities.
Requirements:
- Bachelor's degree in Life Sciences or equivalent education/experience.
- Awareness of post-NOC changes.
- Understanding of pharmaceutical production processes, including manufacturing, packaging, and testing.
- Minimum 5 years of experience in Pharmaceutical Quality Control/Quality Systems.
What We Offer:
We offer a competitive salary of $80,000 - $110,000 per year, depending on experience, plus additional benefits such as medical, dental, and vision insurance, 401(k) matching, and paid time off.
Why Join TCS?
TCS operates on a global scale, with a diverse talent base representing 153 nationalities across 55 countries. We have been recognized as a Global Top Employer by the Top Employers Institute and have made significant investments in digital technology and horizontal platforms.
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