Product Release Compliance Specialist

3 weeks ago

Toronto Ontario, Ontario, Canada Tata Consultancy Services Full time

About TCS:


TCS operates on a global scale, with a diverse talent base of more than 600,000 associates representing 153 nationalities across 55 countries. TCS has been recognized as a Global Top Employer by the Top Employers Institute - one of only eight companies worldwide to have achieved this status. Our organizational structure is domain-led and designed to offer businesses a single window into industry-specific solutions. Our agile industry units have embedded capabilities to enable rapid responses that provide a competitive edge to our customers. This, coupled with a unique Global Network Delivery Model™ (GNDM™), is recognized as the current benchmark of excellence in technology deployment. We have made significant investments in digital technology, horizontal, and vertical platforms, allowing us to successfully serve our clients for over 50 years.


Skills Required:


• 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.

• Good years of experience in Pharmaceutical Quality Control/Quality Systems.

• Understanding of pharmaceutical production processes i.e. manufacturing, packaging, and testing.


Major Responsibilities:


• Review and assess analytical, manufacturing and packaging documentation for finished products to ensure compliance to 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.

• Support the product returns process to ensure all requirements are met for return to stock or recommend rejection.

• Maintain predefined performance expectations.


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.


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.

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