Senior Specialist

Job Description

Job Description

The resource will be part of a team with multifaceted strengths

The role will execute the activities of the Quality Operations team responsible for deviation management, BRR and projects also supporting the Supervisor for coordination.

Main activities:

• Responsible for achieving the quality objectives
• Independently coordinates projects assigned and the resources (if any)
• 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
• 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
• 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
• 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

Requirements:

• Graduated in CTF, Pharmacy, Biologty, Biotechnology
• At least 3 years of experience in the same role
• Preferred Knowledge of: Investigation process, deviation process, batch record review, QC Out of specification and laboratory event
• Fluent knowledge of English
• Experience in client management
• Preferred experience in team management

Come to work with us

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