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Compliance QA Specialist
Apotex Inc.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.
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- Bonus programs based on position
- Comprehensive benefits
- Pension plan to help save for retirement
- Learning and development opportunities
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Quality SystemsComplianceAuditing techniquescGMP regulationsGMP trainingStandard Operating ProceduresRisk assessmentCompliance impact assessmentsPharmaceutical regulationsAPI manufacturing
Soft Skills
LeadershipOrganizational skillsCommunication skillsAttention to detailProblem-solving