Senior Quality Assurance Specialist
4 weeks ago
Job Title: Senior Quality Assurance Specialist
Job Summary:
We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Bayshore HealthCare. As a key member of our Quality Assurance department, you will be responsible for ensuring the highest standards of quality and compliance across our organization.
Key Responsibilities:
- Develop and implement quality standards and systems to ensure regulatory compliance
- Conduct audits and inspections to ensure compliance with Good Distribution Practices (GDP), Good Manufacturing Practices (GMP), and Medical Devices Regulations (MDR)
- Collaborate with cross-functional teams to drive quality and compliance initiatives
- Lead the coordination of external audits and regulatory inspections
- Manage quality review and approval processes for GMP activities, including batch records and associated documents
- Develop and maintain effective working relationships with internal and external stakeholders
Requirements:
- Bachelor's degree in Life Sciences or related field
- At least 5 years of experience in a Quality role in the Healthcare industry
- Knowledge of Health Canada GMP, ICH, GDP, ASQ, and ISO guidelines
- Excellent analytical, observation, and problem-solving skills
- Ability to thrive in a cross-functional environment and promote collaboration
What We Offer:
Bayshore HealthCare offers a dynamic and supportive work environment, competitive compensation and benefits package, and opportunities for professional growth and development.
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