Quality Assurance Specialist
hace 3 semanas
Job Summary
This position is responsible for ensuring the overall quality of the distribution center. The role acts in compliance with drug, medical device, and local regulations, ensuring quality processes are maintained through procedures, training, and regular inspections.
Key Responsibilities:
- Ensures all staff is trained in their respective job functions, including GMP.
- Writes and revises Standard Operating Procedures as required.
- Conducts regular inspections of the facility and recordkeeping, summarizing and reporting findings.
- Coordinates or assists with corrective actions and preventative measures.
- Communicates with clients and provides information during external audits.
- Liaises with Health Canada officials during regulatory audits.
- Provides feedback and assistance to Customer/Client QA-related questions and concerns.
- Monitors processes and systems within the Department to ensure regulatory compliance and effective operation.
- Investigates discrepancies and problems, advising the appropriate individuals of findings.
- Assists in developing pro-active strategies as a preemptive measure against potential future problems with systems or processes.
- Completes NCR reports and change control requests, providing necessary follow-up.
- Performs maintenance, support, and continuous improvements of Quality Systems.
- Participates actively in manufacturing activities, before, during, and after, to ensure product release.
Qualifications:
Pharmaceutical or healthcare experience preferred. Quality Assurance experience preferred. Bachelor's Degree in a Science-related field (or internationally comparable degree) required; QFB, QFI, or FI preferred.
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