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Job ID :
72242BR
Location :
Italy - Ferentino
:
Job Description
MAIN RESPONSABILITIES:
  • Supervise and coordinate quality compliance activities related to the specific major PDS projects assigned as well as the activities assigned to the team
  • Manage major/critical Complaints and Deviations and lead the team in managing minor/major deviations, investigation & compliant
  • Collaborate actively with the Manager, in the search for corrective and / or preventive actions to achieve maximum efficiency and effectiveness of the processes
  • Participate actively in all project meetings, promptly updating colleagues and Manager on QO tasks progress and timeline
  • Collaborate with PDS colleagues in organizing technical and management meetings with customers
  • Participate and / or lead customer audits based on plant requirements
  • Actively participate in regulatory inspections (Audit)
  • Responsible for achieving the "zero past two" target in deviations, complaints and CAPA, and the RFT and OTD target according to company goals
  • Verify the effectiveness of corrective actions;
  • Schedule and ensures that the document review activities (deviations, eBR, QAT, PSF) for batch release are performed within the timeline defined by the plan
  • Supervision of the preparation of the Annual Product Review and guarantee its execution within the due date
  • Schedule the Specification issuing according to pplan and guarantee the deliver/issuing of the rPDS relevant documentation
  • Collaborate with Compliance colleagues in the review of the Quality System SOPs
  • Revision of the Patheon PDS-Customer Quality Agreements
  • Cooridnate the prompt evaluation of change request
  • Provide customers with tlc and email support by answering quality queries
  • Coordinate and develop the direct reports assigned with training, feedback and coaching
  • Perform evaluation of the middle and end year of the assigned resources working by enhancing current resources professionalism, expertise & Skills;
  • Participate actively in the preparation of the monthly meetings "Quality Town Hall"
  • Lead "quality continous improvements" and supports initiatives in the field of Operational Excellence

REQUIREMENTS:
  • Bachelor’s Degree in Biology or related technical field.
  • 5+ years’ of experience in pharmaceutical, biotech industry
  • Fluent English
  • Strong organizational skills
  • Strong verbal and written communication skills.
  • Strong interpersonal skills and ability to work efficiently on a team.
  • Strong Knowledge of FDA and international regulations and GxP guidelines


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