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

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