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Quality Assurance Director
2 months ago
**Job Summary**
We are seeking a highly experienced Quality Assurance Manager to join our Life Science company. The successful candidate will be responsible for ensuring the quality and compliance of our products and processes.
Key Responsibilities:
- Develop and implement quality management systems to ensure compliance with regulatory requirements.
- Conduct regular audits and inspections to identify areas for improvement.
- Collaborate with cross-functional teams to resolve quality-related issues.
- Develop and maintain standard operating procedures (SOPs) and quality documents.
- Review and approve validation protocols and reports.
- Liaise with suppliers and contractors to ensure compliance with quality standards.
- Develop and implement training programs for staff.
- Conduct internal and external audits to ensure compliance with regulatory requirements.
- Execute and enforce quality agreements with suppliers and contractors.
Requirements:
- Minimum BSc in a life science or pharmaceutical science.
- Minimum 8 years of QA experience in a pharmaceutical GMP environment.
- Pharma and/or biotech experience.
- Experience in conducting onsite and external audits to ensure compliance with GMPs.
- Thorough understanding of Canadian GMP and ICH requirements for the manufacturing and release of drug products.
