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About the role

  • Quality Systems Specialist at Apotex overseeing compliance and maintaining Quality Systems in the Pharmaceutical Industry. Leading audits, training, and developing regulatory procedures for operational excellence.

Responsibilities

  • Development, execution and maintenance of effective Quality Systems and ensuring Compliance
  • Responsible for supporting Quality Culture through Compliance and Quality System program/system scheduling, execution and monitoring for effectiveness
  • Manages audit program by scheduling and leading self-inspections
  • Ensures appropriate corrective and preventative actions are taken to close-out audit reports
  • Conducts external audits
  • Develops, schedules and delivers the on-going GMP training and certification programs
  • Writes, updates and reviews Standard Operating Procedures and risk assessment reports
  • Completes compliance impact assessments and participates in or coordinates implementation of major system changes

Requirements

  • Education at the University level in a related scientific discipline
  • Strong practical knowledge of pharmacopoeial requirements and other related regulatory guidelines
  • Proven experience in effective auditing techniques covering documentation, system operations, and operational activities in pharmaceutical environment
  • Minimum seven years of regulatory compliance and quality experience in the Pharmaceutical Industry with focus on quality systems
  • Strong practical experience in interpretation and application of cGMP pharmaceutical regulations and guidelines (Canada, USA, ICH)
  • Experience in developing and delivering CGMP training.
  • Strong proficiency in computer applications and programs such as Word, Excel and Project Management related software
  • Good understanding of API manufacturing environment

Benefits

  • Bonus programs based on position
  • Comprehensive benefits
  • Pension plan to help save for retirement
  • Learning and development opportunities

Job title

Job type

Full Time

Experience level

SeniorLead

Salary

CA$62,854 - CA$83,805 per year

Degree requirement

Bachelor's Degree

Location requirements

OnsiteBrantfordCanada

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