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Sheeden BernardSB

Sheeden Bernard

Quality Document Writing

€450/day
Paris, FR
3-7 years

Average response time: 1 hour

Freelancer profile translated to English.
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About Sheeden

With solid experience in the pharmaceutical industry (Servier, Cenexi), I have learned that compliance is not just a checklist, but the engine of a company's quality and safety.

Today, with SK Compliance & Training, I support organizations in implementing and optimizing their Quality Management Systems (QMS).

My approach? Combining the rigor of industry standards with tailored agility for your structure.

▫️ Audit & Diagnosis: Assessment of the robustness of your processes and identification of risk areas.

▫️ Consulting & QMS: Creation, deployment, and management of high-performing and pragmatic quality systems.

▫️ Training: Supporting your teams to durably embed best practices.

My background in both System QA (strategic) and Operational QA (field) allows me to understand your real challenges. I don't just deliver procedures: I ensure they are applicable and understood.

- Pedagogy & Enthusiasm: I make complex subjects accessible and motivating for your employees.

- Rigor & Flexibility: The framework is strict, but the solution must be adapted to your business reality.

- Attentive: Every structure is unique, and so is my support.

Thanks to my expertise in QMS, I undertake concrete missions to ensure your compliance:

- Quality Audits & Diagnostics: Internal audits, preparation for regulatory inspections, and supplier evaluations to identify and correct your vulnerabilities.

- QMS Engineering: Creation, updating, and simplification of your quality documentation for an agile and efficient system.

- Tailored Training: Raising awareness among your employees about best practices and quality culture.

Committed to excellence: I apply pharmaceutical industry standards to all my consulting missions.
  • French

    Native or bilingual

  • English

    Fluent

Can work on-site
Paris (up to 50km), Orléans (up to 10km)

Experience

  • CENEXI CDMO
    Quality Assurance Officer
    PHARMACEUTICALS INDUSTRY
    December 2022 - Today (3 years and 8 months)
    Fontenay-sous-Bois, France
    • **Compliance Management**: Guarantee of compliance with GMP, GDP, and Data Integrity for all analytical activities.
    • **Deviation Management**: Expertise in handling non-conformities (Deviations, OOS, OOT) and monitoring corrective and preventive action plans (CAPA).
    • **Monitoring & Audit**: Conducting field diagnostics (Flash audits, Housekeeping), active participation in client audits, and regulatory watch.
    • **Documentary System & Performance**: Approval and maintenance of quality documentation, change control monitoring, and performance indicator (KPI) management.
    • **Training**: Onboarding and skill development of employees on quality processes (GMP, deviation management).
    Procedure Implementation Process Implementation Non-conformity Management Quality Management System Definition and monitoring of indicators (KPI)
  • Laboratoire Servier Industrie Gidy
    System Quality
    ENVIRONMENTAL
    September 2019 - September 2022 (3 years)
    Orléans, France
    Implementation of a Quality Management System for ISO 17025 certification;
    Management of improvement actions (PDCA);
    Writing and implementation of procedures;
    Management and handling of non-conformities (5M, CQQCOQP);
    Document and record management (DMS, EXCEL, Network);
    Mastery of risk analysis (FMEA);
    Implementation of Quality and analytical indicators (dashboard).
    Quality Management System Procedure Implementation ISO Certification Risk Analysis Definition and monitoring of indicators (KPI)

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Education

  • Master double degree in Analysis & Quality Assurance
    University of Paris-Est-Créteil
    2022
    Master double compétence
  • Professional Bachelor's degree in Industrial Quality Assurance
    University of Paris Cité & ETSL
    2020
    Industrie des Pharmaceutiques, cosmétologiques et de santé : Gestion, production et valorisation - option Assurance Qualité Industrielle

Certifications

  • Create and develop a professional training business
    UP&COM Certification

Skill set

Categories

  • Other