Compliance and Quality Assurance Specialist
5 days ago
The Compliance and Quality Assurance Specialist will act as a consultant and is responsible for planning and executing quality assurance deliverables while overseeing and evaluating the work performed by pharmaceutical product suppliers. This role requires advanced knowledge and experience in API and CMO quality assurance, Health Canada and FDA regulations, laboratory standards, and industry standards in API production and CMO facilities with a strong understanding of Good Manufacturing Practices (GMP).
Key Responsibilities:
- Review and execute quality management systems (QMS)
- Develop and manage policies, procedures, work instructions, deviations, change control, and corrective action plans
- Investigate quality concerns, resolve issues, and follow up on corrective actions
- Monitor and evaluate quality indicators, QA reports, and audit responses
- Submit change notifications and applications to applicable authorities
- Set specifications for substances, materials, and intermediates
- Perform in-process and batch reviews
- Prepare reports on out-of-specification (OOS) results and critical deviations
- Provide test procedures, quality statements, stability reports, and other documents
- Perform annual product quality reviews (APQR)
Qualifications:
- A degree in chemistry, biology, pharmacology, or food science
- 3+ years of experience in quality assurance/control in GxP regulated industries
- Strong knowledge of GMP, QMS, quality risk management, lean manufacturing, and validation principles
Working Conditions:
- Bilingual: French and English
- Working onsite and remotely
- Must be available to travel occasionally
Company Overview:
Mivado GlobalPerformance Inc is a leading provider of quality assurance services to the pharmaceutical industry.
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