Product Release Compliance Specialist
20 hours ago
Company Overview:
Tata Consultancy Services (TCS) is a global IT services, consulting, and business solutions organization. With over 55 years of experience, we have been partnering with many of the world's largest businesses in their transformation journeys.
About Us:
We are committed to creating a diverse and inclusive workforce that reflects the societies we operate in. Our continued commitment to culture and diversity is reflected in our people stories across our workforce implemented through equitable workplace policies and processes.
Career Opportunities:
We are seeking a Product Release Compliance Specialist to join our team. This role will be responsible for ensuring timely and compliant release of products to the Canadian market.
Job Description:
The Product Release Compliance Specialist will ensure regulatory compliance of all JI products through maintaining compliant specifications/standards (RSSs) and manages 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).
Key Responsibilities:
- Ensure ongoing product compliance to Canadian Regulations and J&J Quality requirements through review and evaluation of Supplier Release Documentation and Executed Batch Reviews.
- Support investigations of deviations/non-conformances to ensure closure in a timely and compliant manner, and any related corrective/preventive actions are in place.
- Review and assess analytical, manufacturing and packaging documentation for finished products to ensure compliance with requirements/marketing authorization to recommend product disposition (approve/reject).
- Autorize the release of inventory in the SAP system ensuring accurate quantities, material status, and expiration date.
- Build and maintain relationship with supply sites, wholesalers, and key internal partners.
Required Skills and Qualifications:
To be successful in this role, you will need:
- B.Sc. in life sciences (Pharmacy, Biology, Physiology, Chemistry, Microbiology, Biotechnology, Biochemistry or equivalent education/experience).
- Awareness of Post NOC changes.
- Understanding of pharmaceutical production processes i.e. manufacturing, packaging, and testing.
Estimated Salary:$120,000 - $150,000 per year
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