QA Compliance Specialist
4 weeks ago
This role is responsible for planning and executing Quality Assurance deliverables, overseeing and evaluating the work performed by the pharmaceutical product supplier, and providing mentoring to the Quality Assurance staff.
Key Responsibilities:- Review and execute Quality Management Systems (QMS)
- Develop and manage policies, procedures, work instructions, deviations, CAPAs, and change controls
- 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 results and critical deviations
- Provide test procedures, quality statements, stability reports, and other documents
- Perform annual Product Quality Review (APQR)
- Bachelor's degree in Chemistry, Biology, Pharmacology, or Food Science
- At least 3 years of experience in Quality Assurance/Control in GxP regulated industries
- Strong knowledge of GMP, QMS, QRM, Lean Manufacturing, and Validation Principles
- Bilingual: French and English
- Onsite and remote work
- Occasional travel required
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