Job ID :
Italy - Ferentino
- 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
- 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