other in Arras

You will be responsible for the operational preparation of equipment in the sector, including filling lines, lyophilizers, isolators, and stopper processors

You will guarantee the correct application of applicable standards within the support departments under your responsibility, acting as the Quality support and point of contact for operational teams

You will evaluate plasma product batches to ensure compliance with registration dossiers and regulatory standards for certification and release

You will participate in chemical risk assessments and work on action plans, as well as contribute to the evaluation of the professional risk document

You will participate in the follow-up and reporting of activities on automated tools and assist in investigating deviations during therapeutic batches

You will participate in the qualification of the Maldi-Tof for microorganism identification

Contribute to the Contamination Control Strategy (CCS) process, including periodic reviews and definition for new sectors/products

You will participate in the development of quality indicator tracking tools and improve the mapping of quality processes for oversight

You will gain skills in implementing the ERP, optimizing service activities, participating in project management, and assisting in procedure writing

You will participate in quality assurance processes and contribute to the implementation of quality processes, including batch certification and annual product quality reviews

You will participate in the implementation of continuous improvement tools such as KPI tracking, 5S, and CAPA

You will contribute to the implementation and monitoring of Data Integrity (DI) processes and associated regulations at the Arras industrial site

You will participate in trials for the commissioning of workshops, including environmental IQ/OQ/PQ

You will be responsible for writing deliverables for equipment qualification, researching technical information, and staying updated on the state of the art and regulations

Assist in the implementation of the qualification and validation program for critical fill & finish equipment

You will participate in the development of the Validation strategy and assist in drafting protocols and reports in compliance with regulatory documentation

You will contribute to the implementation of the documentation tree of the Commissioning and Qualification (C&Q) Arras service, taking into account existing documentation

You will participate in the development of the validation strategy and contribute to the writing of protocols and reports in compliance with group rules and regulatory documentation

You will participate in trials for workshop commissioning, including monitoring test batches, engineering runs, QP, validation batches, and therapeutic batches

Diriger, coordonner et animer une équipe afin de réaliser les programmes de son activité en respectant les BPF, les règles d’hygiène et de sécurité dans les quantités et les délais impartis

You will gain expertise in handling deviations, coordinating root cause analyses, and documenting impact assessments within the Industrial Department

Vous serez garant(e) de la conformité des systèmes aux exigences réglementaires et participerez activement à la sécurisation des données et des processus

Your missions will include performing the inspection stages of pharmaceutical products in compliance with GMP, hygiene and safety rules, and deadlines

Participate in trials for workshop commissioning, including QP, validation, and therapeutic lots

You will be responsible for managing process validation projects, including writing protocols and reports in accordance with group rules and regulatory documentation