Quality Assurance Specialist for Pharmaceutical Industry

Company Overview

We are a leading Fortune Global 500 organization, dedicated to providing innovative solutions and rewarding experiences. Our culture is built on teamwork, skill development, and passion.

Job Description

This position plays a critical role in ensuring the quality of our distribution center, adhering to drug, medical device, and local regulations. The ideal candidate will have a strong background in Quality Assurance, with experience in implementing procedures, training, and regular inspections.

Responsibilities

• Ensure compliance with regulatory requirements, including Article 52 of Italian Law No. 219/06.
• Develop and maintain Standard Operating Procedures, including GMP training for staff.
• Conduct regular facility inspections, recordkeeping, and summarization of findings, as well as coordinate corrective actions.
• Communicate effectively with clients during external audits and liaise with Health Canada officials.
• Provide feedback and support to QA-related questions and concerns from customers.
• Monitor processes and systems for regulatory compliance and effective operation.
• Investigate discrepancies and advise relevant parties.
• Develop proactive strategies to prevent future problems.
• Complete NCR reports and change control requests, with necessary follow-up.
• Maintain and improve Quality Systems, including QPIC designation duties.

Salary

$85,000 - $115,000 per annum, depending on experience and qualifications.

Benefits

Our comprehensive benefits package includes health insurance, retirement plan, and paid time off.