Team Leader, BRR & Investigation [Italy]


 

Job Description

The resource will be part of a team with multifaceted strengths!

The role will Supervises and coordinates the activities of the Quality Operations team responsible for deviation management, BRR and projects.

It is responsible for achieving the quality objectives. It independently coordinates the resources and projects assigned. It performs the training of the personnel involved in the quality operations activities and performs the training, for the topics of its competence, to all site personnel; It deals the Deviations, finalizing both personally and reviewing the investigations performed by the Quality Operations Specialist and Specialist II; Actively collaborate 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 meetings projects, regularly updating colleagues and Responsible for the state of current projects. Participates and/or conducts Client/Regulatory Audits.

It is involved for drafting and reviewing Risk Assessment for the assessment of the risks associated with quality events; Organizes and ensures that document review activities (deviations, QAT, SOP) for batch release are performed within the timelines defined by the plan. Support the revision of Quality Agreements - Client assigned; It guarantees a quality interlocutor, for each Client/project, in order to provide timely and constant support for QO topics; Provides Client via TC and email support answering quality questions; Collaborate with the business and other colleagues of the PDS/Large Parenteral Volume BUs in the organization of technical and management meetings with Clients.

Leads the BRR team, coordinating BRR and archiving activities. Reviews the release and compliance documents. Coordinates and assure the development of the team assigned with training, feedback and mentor. It performs middle and end year evaluation of the assigned resources working in concert with its manager in identifying the potential of each team member. Research, in collaboration with other plant structures, the improvement of processes in the field of "quality continuous improvements" and supports PPI initiatives. Ensures an appropriate revision of the GMP documentation to confirm compliance with current regulations, national and international guidelines and corporate standards.

Come to work with us!

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