Product Release Compliance Specialist
4 weeks ago
TCS is an equal opportunity employer, and embraces diversity in race, nationality, ethnicity, gender, age, physical ability, neurodiversity, and sexual orientation, to create a workforce that reflects the societies we operate in. Our continued commitment to Culture and Diversity and is reflected in our people stories across our workforce implemented through equitable workplace policies and processes.
About TCS
Tata Consultancy Services is an IT services, consulting, and business solutions organization that has been partnering with many of the world’s largest businesses in their transformation journeys for over 55 years. Its consulting-led, cognitive powered portfolio of business, technology, and engineering services and solutions is delivered through its unique Location Independent Agile™ delivery model, recognized as a benchmark of excellence in software development. A part of the Tata group, India's largest multinational business group, TCS has over 615,000 of the world’s best-trained consultants in 55 countries. The company generated consolidated revenues of US $27.9 billion in the fiscal year ended March 31, 2023, and is listed on the BSE and the NSE in India. TCS' proactive stance on climate change and award-winning work with communities across the world have earned it a place in leading sustainability indices such as the MSCI Global Sustainability Index and the FTSE4Good Emerging Index.
Skills and Responsibilities:
•Ensures the timely and compliant release of product to the Canadian Market.
•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).
•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.
•Other departmental tasks as assigned.
•Review and assess analytical, manufacturing and packaging documentation for finished products to ensure compliance with requirements/marketing authorization to recommend product disposition (approve/reject).
•Evaluate changes to master production documentation to ensure alignment to marketing authorization (in collaboration with RA CMC).
•Authorize 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.
•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).
•Review of Confirmatory Testing protocols and reports.
•Revise Standard Operating Procedures and Work Instructions as required.
•Participate in other quality projects as required.
Roles and Responsibilities:
•Support the product returns process to ensure all requirements are met for return to stock or recommend rejection.
•Maintain predefined performance expectations.
•B.Sc. in life sciences (Pharmacy, Biology, Physiology, Chemistry, Microbiology, Biotechnology, Biochemistry or equivalent education/experience.
•Awareness of Post NOC changes.
•Understands principles of product change management and the impact on marketing authorization.
•Pharmaceutical Quality Control/Quality Systems.
•Understanding of pharmaceutical production processes i.e. manufacturing, packaging, and testing.
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). Should you require accommodations during the recruitment and selection process, please inform Human Resource.
Thank you for your interest in TCS. Candidates that meet the qualification for this position will be contacted within a 2 week period. We invite you to continue to apply for other opportunities that match your profile.
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