Skills

  • Project Management
  • ISO 9001:2015
  • ISO 13485
  • Quality Management system
  • Quality Auditor
  • Pharmaceutical QC & QA
  • GDP
  • RP
  • Manufacturing Processes
  • eQMS
  • Warehouse Managerment

Experience

Maria Hajje

Work experience

Maria Hajje

Work experience
  • Quality Reviewer at   invoX
  • · Quality and compliance oversight of Vendors.
  • · Quality function signatory on internal/external projects.
  • · Maintenance of the company ISO 13485 certification.
  • · Establish Pre-Approval Inspection (PAI) readiness at strategic commercial partners.
  • · Preparation, lead and reporting of external audits.

Maria Hajje

Work experience
  • · Implementation, execution, monitoring, and compliance of the Quality Systems in support of the release for sale activities.
  • · GDP release of pharmaceutical products.

Maria Hajje

Work experience
  • Product Quality Coordinator at   argenx
  • · Management of product quality complaints for commercial and development programs globally.
  • · Coordinate and support quality governance to facilitate quality management review, change control and deviation workflows.
  • · Assist in the handling and processing of product defect reporting to Health Authorities worldwide.

Maria Hajje

Work experience
  • QA Systems Officer  at   UCB
  • · Quality Management System maintenance and implementation
  • · Supplier evaluation management
  • · Utilities/Facilities QA support
  • · Audit management (internal, external audits and Health authorities)

Maria Hajje

Work experience
  • Regional Quality Partner  at   UCB
  • March, 2018 - September, 2020
  • Fulltime
  • · Oversee the Quality Management System life cycle management for the world-wide UCB affiliates (EMEA, APAC, Americas) as part of the Regional Quality Organization.
  • · Report on the QA deliverables and GxP status of the affiliates in accordance with GxP, UCB and national legal Requirements.

Maria Hajje

Work experience
  • Consultant for UCB as QA GMP Specialist  at   Avertim
  • September, 2016 - February, 2018
  • Fulltime
  • · Establishment, review, and approval of Quality Agreements including Gap analysis and Risk
  • assessments.
  • · Cooperation in the management of diverse Alliance Partnerships.
  • · Lead the training and workshops for several teams such as the supply chain (operators and managers) team, Master planner team and QA alliance team.
  • · Building Management Review Meetings for Partners and Carriers.

Maria Hajje

Education
  • Masters in Biotechnology Engineering  at   ENSTBB
  • Focused on:
  • · Biotechnology
  • · Bioproduction
  • · Engineering sciences
  • · Project management

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