Quality System Manager

1 giorno fa


Roma, Lazio, Italia Jefferson Wells A tempo pieno
Quality System & GMP Compliance Manager

Jefferson Wells is seeking a highly skilled Quality System & GMP Compliance Manager to join our team. As a key member of our organization, you will be responsible for ensuring the highest standards of quality and compliance in our pharmaceutical operations.

Main Responsibilities:
  • Develop and Implement Quality Strategy: Define and execute a comprehensive quality strategy that aligns with national and international GMP standards, ensuring continuous improvement and compliance.
  • Support Quality System Improvement: Facilitate the ongoing improvement of our Quality System, ensuring timely updates to cGMP regulations and international pharmaceutical standards.
  • Document Control and Training: Ensure that site documentation is prepared and maintained in accordance with GMP guidelines and our company's quality standards, and that employees are properly trained on GMP procedures.
  • Change Control and Notification: Manage and monitor Change Control processes, ensuring accurate and timely notification to AIFA in accordance with current guidelines.
  • Vendor Qualification and Audit: Ensure that vendors are qualified in accordance with our company's guidelines and GMP standards, and that annual audits are conducted and monitored.
  • Stability and Analytical Method Validation: Ensure the preparation and submission of stability and analytical method validation protocols and reports in accordance with current guidelines.
  • Site Master File and Quality Council: Maintain the Site Master File up-to-date and lead the Quality Council, ensuring regular reporting of quality parameters and identifying trends.
  • Pest Control and Inspection Readiness: Supervise and monitor pest control activities and ensure inspection readiness, including CAPA planning and timely closure of activities.
  • CSV and Data Integrity: Ensure the up-to-date VMP-CSV and coordinate all aspects of validation and re-validation of CS and data integrity.
  • Employee Training and Budget Management: Ensure that employees follow safety procedures and wear required PPE, and establish and monitor departmental objectives and budget.

Preferred location: Frosinone or Latina. Temporary position - Level A3 CCNL Chimico Farmaceutico.


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