Regulatory Affairs Submission

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 Pharmacy, Chemistry, Microbiology, Biotechnology, or Biochemistry or equivalent (education/experience).

•Knowledge 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:

•Receive and perform intake of product quality complaints (PQC, and combined AE/PQC) from any source into the Quality Complaint Handling System in accordance with current regulation and corporate procedures.

•Monitor complaints entered in the Quality Complaint Handling System to ensure all required outreach activities/task actions are completed.

•Follow-up with customers, as required to obtain requested information for the complaint record.

•Ensure field samples are retrieved in a timely manner and complete timely follow-up of field sample return.

•Manage PQC mailbox, ensuring all PQC complaints are entered on time and PQC queries are addressed.

•Monitor POLO PQCs and ensure they are forwarded to the appropriate supplier for complaint investigation.

•Ensure ongoing product compliance to Canadian Regulations and J&J Quality requirements through review and evaluation of Annual Product Reviews (APRs), Annual Stability reports, Supplier Release Documentation and Executed Batch Reviews.

•Review and revise Standard Operating Procedures and Work Instructions, as required.

•Initiate, assess, and perform tasks related to change controls applicable to Canadian products.

•Partner/collaborate with key internal and external business partners to establish priorities to support product compliance activities.

•Participate in other quality activities, as required.

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.