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Healthcare Quality Assurance Specialist

2 mesi fa

Bardi, Emilia-Romagna, Italia Ups A tempo pieno

**Job Summary**

This position is responsible for monitoring the overall quality system status of the distribution center. The ideal candidate will ensure compliance with regulatory requirements and maintain quality processes through the implementation of procedures, training, and regular inspections.

Key Responsibilities:

  • Guarantee compliance with regulatory requirements, including Article 52 of the Italian Legislative Decree 219/06.
  • Ensure all staff is trained in their respective job functions, including Good Manufacturing Practices (GMP).
  • Develop and revise Standard Operating Procedures as required.
  • Conduct regular inspections of the facility and recordkeeping, including summarization and reporting of findings.
  • Coordinate or assist with corrective actions and preventative measures.
  • Communicate with clients and provide information during external audits.
  • Liaise with regulatory officials during audits.
  • Provide feedback and assistance to customer/client quality-related questions and concerns.
  • Monitor processes and systems within the department to ensure regulatory compliance and effective operation.
  • Investigate discrepancies and problems, and advise the appropriate individuals of the findings.
  • Assist in the development of proactive strategies as a preemptive measure against potential future problems with systems or processes.
  • Complete Non-Conformance Report (NCR) and change control requests, and provide necessary follow-up.
  • Perform maintenance, support, and continuous improvements of quality systems.
  • Perform duties related to Quality Process Improvement and Control (QPIC) designation.

Qualifications:

  • Pharmaceutical, healthcare, or food industry experience is preferred.
  • Quality assurance experience is preferred.
  • Bachelor's degree in a science-related field (or internationally comparable degree) is required.
  • QPIC/AQPIC designation is preferred.