Senior QA Engineer ensuring quality across a data - heavy B2B product. Shaping test strategies and verifying correctness from UI to database integrations.
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
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