QA Compliance Specialist

Job Summary

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 the pharm product supplier and providing mentoring to the Quality Assurance staff. This role requires advanced knowledge and experience in API and CMO quality assurance, Health Canada and FDA regulations, laboratory standards and industry standards in the API production and CMO facility with a strong understanding of GMP.

Areas of Responsibilities

• Review and execute Quality Management Systems (QMS)
• Develop and manage policies, procedures, work instructions, Deviation, CC and CAPA
• Investigate quality concerns; resolve and follow-up on corrective actions
• Monitor, evaluate quality indicators, QA reports and audit responses
• Submit change notification/application to applicable authority
• Set specifications foe substance, materials and intermediates
• Perform in-process and Batch review
• Prepare reports on OOS, critical deviation
• Provide test procedure, quality statements, stability reports, and other documents
• Perform annual Product Quality Review (APQR)

Qualification

• A degree in Chemistry, Biology, Pharmacology or Food Science
• Member of Ordre des chimistes du Québec
• 3+ years experience in Quality Assurance/Control in GxP Regulated industries
• Strong knowledge of GMP, QMS, QRM, Lean Manufacturing & Validation Principles

Working Conditions

• Bilingual : French and English
• Working Onsite and Remotely
• Must be available to travel occasionally