Team Leader, Brr - Ferentino, Italia - Thermo Fisher Scientific
Descrizione
Position scope/Responsibility:
Supervises and coordinates the activities of the Quality Operations team responsible for deviation management, BRR and projects. Team Leader is responsible for achieving the quality objectives. He/she independently coordinates the resources and projects assigned.
Specific tasks/activities:
- Supervises and coordinates quality operations related to the management of deviations and projects assigned to self and to the specific dedicated team.
- Trains the personnel involved in the quality operations activities and, for the topics of competence, all site personnel;
- Deals with the Deviations, finalizing both personally and reviews the investigations performed by the Quality Operations Specialist and Specialist II;
- Actively collaborates with the Manager, in the search of corrective and/or preventive actions to achieve maximum efficiency and effectiveness of the processes;
- Actively participates in the projects meetings, regularly updating colleagues and stays responsible for the state of current projects;
- Participates and/or conducts, according to the needs of the establishment, Client audits
- Participates in regulatory (Audit), Client and internal audit inspections;
- Is responsible for achieving the site objectives in the area of batch release;
- Verifies the effectiveness of corrective actions over time;
- Is responsible for drafting and reviewing Risk Assessment for the assessment of the risks associated with quality events;
- Coordinates and ensures that document review activities (deviations, QAT, SOP) for batch release are performed within the timelines defined by the plan
- Collaborates with colleagues of Quality System in the revision of the SOP that fall within the scope of the department of belonging;
- Revises Patheon Quality Agreements
- Client assigned;
- Guarantees a quality interlocutor for each Client/project to provide timely and constant support for QO topics;
- Supports in answering quality questions;
- Collaborates with the business and other colleagues of the DPS in the organization of technical and management meetings with Clients;
- Manages the BRR team, coordinates BRR and archiving activities. Reviews the release and compliance documents;
- Coordinates and develops the direct reports assigned with training, feedback and coaching;
- Performs middle and end year evaluation of the assigned resources working together with own manager in identifying the potential of each team member.
- Drafts the monthly meetings "Quality Town Hall", "Quality Council" and "Quality Management Review";
- Researches, in collaboration with other plant structures, the improvement of processes in the field of "quality continuous improvements" and supports initiatives related to PPI.
- Ensures an appropriate revision of the GMP documentation in order to confirm compliance with current regulations, national and international guidelines and corporate standards.
Requirements:
- At least 3 years of experience in QA or Pharmaceutical Production (Sterile Products)
- English (good)
- Problem Solving
- Excellent communication & negotiation skills
- Excellent organizational skills
- Development of our employees
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