Team Leader, Brr

2 settimane fa

Ferentino, Lazio, Italia Thermo Fisher Scientific A tempo pieno
The Quality Difference at

Thermo Fisher Scientific:

What makes our quality teams unique is a shared passion for getting it done right the first time and working for the right reasons with our customers always in mind.

Our team of Quality professionals understand our customers rely on the accuracy, safety, and effectiveness of our products and services that are improving lives around the world.

When you join our team of quality professionals, you'll collaborate on projects on a global scale while being encouraged to grow your skills and discover new career paths with us.


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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