Senior Quality Assurance and Compliance Specialist
5 days ago
Job Overview
Bayshore HealthCare is seeking a highly skilled Senior Quality Assurance and Compliance Specialist to join our team. This role will be responsible for monitoring and maintaining all aspects of the Quality Management System for DEX Medical Distribution Inc. (DEX) and Pharmacy Business Units (BUs) within the Bayshore Specialty Rx (BSRx) division.
Key Responsibilities
- Ensure site compliance with federal and local regulations, as well as internal policies and procedures.
- Maintain oversight of activities carried out by the Qualified Person-In-Charge (QPIC) and A/QPIC for narcotics and controlled drugs.
- Operate and execute the Quality Management System relating to Good Distribution Practices (GDP), Good Manufacturing Practices (GMP), and Medical Devices Regulations (MDR) for DEX and all Pharmacy BUs within the Bayshore Specialty Rx (BSRx) division.
- Define and implement quality standards, systems, and metrics for maintaining regulatory compliance as it relates to the importation, packaging/labeling, wholesale, and distribution of drug products and/or medicinal products for the Canadian market.
- Collaborate across the Operations and divisional Quality team to provide support and drive various Business units (BUs) within the BSRx Division to the most compliant, quality outcomes.
Requirements
- Bachelor's degree in Life Sciences or related field (Chemistry, Biology, or Pharmacy).
- At least 5 years of previous experience working in the Healthcare field in a Quality role.
- Knowledge of Health Canada GMP (Good Manufacturing Practices), ICH (International Conference on Harmonization), GDP (Good Documentation Practices), ASQ, and ISO guidelines.
- Familiar with pharmaceutical equipment, utilities, and validation concepts.
Estimated Salary: $120,000 - $150,000 per year, depending on experience.
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