Regulatory Compliance Specialist for Pharmaceutical Products

1 day ago

Canada Tata Consultancy Services Full time

Job Overview

Tata Consultancy Services is a leading IT services, consulting, and business solutions organization that partners with global businesses in their transformation journeys. Our team is seeking a Regulatory Compliance Specialist for Pharmaceutical Products to ensure timely and compliant release of products to the Canadian market.

Key Responsibilities

  • Ensure regulatory compliance of all JI products through maintaining compliant specifications/standards (RSSs) and managing change to those standards.
  • Assess 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.

Requirements

  • Bachelor's degree in Life Sciences (Pharmacy, Biology, Physiology, Chemistry, Microbiology, Biotechnology, or Biochemistry) or equivalent education/experience.
  • Awareness of Post NOC changes.
  • Understanding of principles of product change management and the impact on marketing authorization.
  • Pharmaceutical Quality Control/Quality Systems knowledge.
  • Understanding of pharmaceutical production processes (manufacturing, packaging, and testing).

Compensation Package

We offer an attractive compensation package, including a salary range of $65,000-$85,000 per year, depending on experience and qualifications, plus additional benefits such as health insurance, retirement savings plan, and paid time off.

About Tata Consultancy Services

TCS is an equal opportunity employer and 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). We welcome applications from diverse candidates and encourage them to apply for this exciting opportunity.

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