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Manufacturing Quality Expert

1 mese fa

Roma, Lazio, Italia Thermo Fisher Scientific A tempo pieno

About the Role

We are seeking a Quality Production Specialist to join our team at Thermo Fisher Scientific. This individual will play a crucial role in ensuring the implementation of proven quality standards in a collaborative and ambitious environment. The PDS Manufacturing Quality Specialist will participate in day-to-day operations to assure compliance with manufacturing department activities.

The focus of this position will be to ensure all documentation is complete and accurate. Assisting with internal, client, and regulatory audits will be encouraged to ensure compliance with cGMP requirements. A deep understanding of deviation investigations and CAPA is fundamental for this role. The person will be responsible for the review/creation cycle of departmental procedures, checklists, work instructions, and related practical training and interact positively on quality-related issues internally and externally.

Main Responsibilities

  • Provide documentary support to the production department.
  • Manage CAPAs through the Track Wise system.
  • Open and manage CCF pertaining to the department.
  • Collaborate with the Quality System Department to review SOPs in compliance with GMP, regulatory requirements, and corporate guidelines.
  • Execute training to department staff and their management.
  • Build, review, approve, track, and present documents and procedures required for pharmaceutical regulations.
  • Identify areas of non-compliance, review recommendations, and implement solutions to resolve major quality issues.
  • Perform activities across key quality functions to support manufacturing.
  • Manage internal audits, customer audits, regulatory audits, and all customer visits.
  • Support operational improvements and efficiency improvements for continuous improvement and Operational Excellence.
  • Train personnel according to specific job descriptions, monitor, and verify their activities.
  • Provide support and participate in meetings/calls internally and externally.
  • Assist downstream manufacturing modules to operate efficiently and meet timelines/schedules through SOPs.
  • Collaborate with team members to generate reports on site and corporate performance.