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Senior Quality Assurance Specialist with Environmental Expertise

2 mesi fa


Milano, Lombardia, Italia Healthcare Businesswomen's Association A tempo pieno

Job Overview

A career-defining opportunity has emerged at the Healthcare Businesswomen's Association for a seasoned Quality Assurance Specialist with a deep understanding of environmental monitoring in the pharmaceutical industry/biotech sector. As we continue to drive excellence in quality management systems, we seek an individual who can effectively oversee production and testing activities while ensuring cGxP compliance.

Key Responsibilities:

  • Oversight of all production and testing activities, guaranteeing adherence to cGxP requirements, including data integrity and eCompliance;
  • Support exception investigations to promptly identify and address any issues that may arise;
  • Review and approval of production, QC, and AS and T records to maintain accuracy and efficiency;
  • Maintenance of Minimum Batch Records (MBR) to ensure seamless batch release processes;
  • Collaboration on Operational Excellence (OpEx) improvement projects to drive continuous enhancement;
  • Execution of batch release in compliance with registration requirements as a Qualified Person;
  • Reporting of technical complaints/adverse events/special case scenarios related to Novartis products within 24 hours of receipt;
  • Distribution of marketing samples (where applicable).

Performance Metrics:

  • On-time and GMP-compliant release of dosage forms;
  • No complaints about inspections by authorities in your area of responsibility without prior notification and communication;
  • Successful support of continuous improvement projects;
  • Accurate execution of batch release in compliance with registration.

Requirements:

  • Work Experience: Proven functional breadth in QC/QA within the pharmaceutical industry/biotech sector, particularly in environmental monitoring;
  • Collaborative mindset with ability to work across boundaries;
  • Experience with cleanliness zones;
  • Fundamental skills: Continuous learning, dealing with ambiguity, GMP procedures, QA, Quality Control (QC) testing, Quality standards, Self-awareness, Technological expertise, and Technological intelligence;
  • Languages: English.

Estimated Salary Range: $120,000 - $150,000 per annum, commensurate with experience.