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Ahlem HajAH

Ahlem Haj

Quality Engineer | QMS, GMP/GDP Audits, ISO 9001

€350/day
Paris, FR
0-2 years

Average response time: 1 hour

Freelancer profile translated to English.
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About Ahlem

Quality Engineer with a dual background in chemistry and quality, I undertake missions to structure or strengthen your Quality Management System, manage your audits, and validate your field practices.

What I bring concretely:
- Implementation and improvement of the QMS (procedures, operating methods, records)
- Management of internal GMP/GDP audits: preparation, execution, reporting, CAPA follow-up
- Management of quality investigations: root cause analysis (5M, QQOQCP, 5 Whys, 8D), definition and follow-up of corrective actions
- Deployment of documentary systems (EDMS, change control, versioning)
- Quality control of raw materials, intermediates, and finished products
- Stability studies of finished products
- Analytical method validation
- Laboratory equipment management

Some results at Calyxia:
- 30% reduction in equipment monitoring time through a digital system
- Training of 45 users in laboratory equipment management
- Management of 5 GMP/GDP internal audits from start to finish
- Complete EDMS project management: configuration, IQ/OQ/PQ testing, coordination with developers,
- Training of 35 users on the new EDMS

Mastered Standards:
ISO 9001 · ISO 22716 · ISO 17025 · GMP · GDP · ISO 13485 · EN 9100 · ISO 14001 ·

Accustomed to regulated and demanding environments, I bring a structured and operational vision of quality, with a real ability to support field teams.

📍 Based in Paris — available in person and remotely.
  • French

    Native or bilingual

  • Arabic

    Native or bilingual

  • English

    Fluent

Can work on-site
Paris (up to 40km)

Experience

  • Calyxia
    Consultant Quality Engineer
    September 2025 - February 2026 (5 months)
    - Conducted internal audits: audit plan, evaluation grid, document review, and on-site audit in preparation for an external audit
    - Managed the EDMS project: implemented the document management workflow (change control, versioning, access rights, archiving), coordinated with developers, configured, performed IQ/OQ/PQ testing, and trained 35 users
    - Provided Quality Support to laboratory and production teams
    Audit Investigations CAPA QMS EDMS
  • Calyxia
    Quality Engineer
    September 2023 - August 2025 (1 year and 11 months)
    - Implemented and improved the Quality Management System
    - Wrote and updated quality documents (procedures, operating methods, and records)
    - Optimized processes through Lean Management. Trained and educated teams on good quality practices
    - Managed 5 GMP/GDP internal audits: compliance review, reports, CAPA follow-up
    - Managed quality investigations (NC, deviations): root cause analysis (5M, QQOQCP), definition and follow-up of CAPAs
    - Defined and monitored Quality KPIs
    - Quality control of raw materials: control strategy, development and monitoring of control plans, supervision of tests, analytical monitoring, and release of raw materials
    - Stability studies of finished products and cleaning validation of production equipment
    - Deployed a digital equipment management system: reduced monitoring time by 30%
    - Managed analytical method validations for quality control
    - Developed an analytical method for measuring the viscosity profile of raw materials
    CAPA GMP/GDP ISO 9001 ISO 17025 ISO 22716
  • Amal
    Association Manager
    January 2020 - January 2024 (4 years)
    - Organizational management: schedule management, team coordination, and administrative reporting
    - Supervised and led scientific sessions with personalized educational follow-up
    - Liaised with partners and external stakeholders
    Team Management Reporting Client Management Project Management

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Education

  • Master Chemistry - Control & Quality
    CYU
    2025
    Master
  • Bachelor of Science in Chemistry
    University of Versailles
    2023
    Licence

Skill set

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