QA Systems Officer Utilities H/F/X

Description de la fonction

Contracting - Brabant Wallon

General QA Role Ensure compliance with all relevant regulatory requirements Organize adequate quality oversight on GMP documentation and activities. Promote leading and proactive management of deviations, corrective and preventative actions and change controls. Actively participate to the quality governance in place within the organization. Ensure appropriate quality indicators are monitored (both leading and lagging) and adhered to. Ensure escalation of significant/critical quality problems to the appropriate levels of management following the standards set by the QMS. Participate in the preparation for regulatory inspections, providing direct support to system owners and main customers during inspections. Promote strong communication within Quality teams and strive for reducing variability to aim for One Quality Voice. Foster a culture of quality, compliance, and continuous improvement within the organization. Beltech Utilities support Together with BIM Teams, ensure direct follow-up of Compliance Audit activities, Deviations, Failure Investigations, Change Control, Qualification/Validation activities and associated documentation approval. Drive the identification of opportunities for improvement, development and implementation of quality and operational excellence projects in response to business requirements, technical changes, identified risks, audit observations and regulatory requirements. Lead or co-lead internal audits to ensure compliance with internal standards and worldwide regulatory requirements with respect to cGMP. Ensure adequate quality reviews (periodic system quality reviews, quarterly utilities monitoring reports) QA follow-up of utilities/Beltech related projects and project management. Using a Risk Based Approach, ensure that all Utilities, HVAC & Cleanroom Systems used Pharma & Injectable, T2, T4 and related supporting services are compliant with applicable regulations and guidelines (EMEA, FDA, PIC/S, ICH, best practices as defined by relevant organizations) and Corporate Policies & Procedures Back up fonction The position can act as back-up for his direct colleagues or for his manager according to the Manager 's instructions and after appropriate training

Profil

Master's degree in a relevant field (e.g., Engineering, Science or a related discipline). Experience in a regulated pharmaceutical environment or other life science or health related field is mandatory Experience with Quality Management Systems and Auditing is an asset Fluent in French, very good level in English is required Affinity for Quality & Compliance and worldwide regulations pertaining to cGMP regulations pertaining to Pharmaceuticals & Medical Devices Team player with good interpersonal relationships and communication skills

Compétences linguistiques

• Français (atout)

  • Comprendre : Expérimenté - (C1)
  • Écrire : Expérimenté - (C1)
  • Lire : Expérimenté - (C1)
  • Parler : Expérimenté - (C1)

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