Healthcare QA Specialist — Regs, Audits & Quality Systems

hcmportal; Marche; In loco; EUR 55.000 - 75.000; Tempo pieno

Descrizione del lavoro

UPS Healthcare Precision Logistics is seeking a Quality Assurance professional to monitor the overall Quality System status at the distribution center, ensuring compliance with drug, medical device, and local regulations. You will implement procedures, provide training, and conduct inspections, coordinating corrective actions and preventive measures.

You will communicate with clients during external audits and liaise with Health Canada officials, supporting QA inquiries.

Competenze

• Pharmaceutical, healthcare or food industry experience - Preferred.
• Quality Assurance experience - Preferred.
• Bachelor’s Degree in Science related field (or internationally comparable degree) required - Preferred
• QPIC/AQPIC designation - Preferred

Mansioni

• 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, including summarization and reporting of findings. Coordinate or assist 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 the processes and systems within the Department to ensure regulatory compliance and effective operation.
• Investigates discrepancies and problems, and advise the appropriate individuals of the findings.
• Assists in development of pro-active strategies as a preemptive measure against potential future problems with systems or processes.
• Completes NCR reports and change control requests and provide necessary follow-up.
• Performs maintenance, support, and continuous improvements of Quality Systems.
• QPIC designation duties.

Conoscenze

GMP knowledge

Regulatory compliance

Audit experience

Formazione

Bachelor’s Degree in Science related field

QPIC/AQPIC designation

Descrizione del lavoro

UPS Healthcare Precision Logistics is seeking a Quality Assurance professional to monitor the overall Quality System status at the distribution center, ensuring compliance with drug, medical device, and local regulations. You will implement procedures, provide training, and conduct inspections, coordinating corrective actions and preventive measures.

You will communicate with clients during external audits and liaise with Health Canada officials, supporting QA inquiries.