This inclusive employer is a member of myGwork – the largest global platform for the LGBTQ+ business community. 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! ***
