Freelancer profile translated to English.
Back to original languageAbout Sheila
Need to secure your quality audits in a regulated environment and obtain a reliable assessment of your systems and partners?
Senior independent consultant specializing in quality audits in the healthcare industries (GMP, ISO 9001, ISO 13485, ISO 22716).
I support pharmaceutical laboratories, biotech, medical devices, and CDMOs in conducting internal audits (1st party) and supplier audits (2nd party).
My interventions allow for an objective evaluation of existing quality systems, verification of their compliance with applicable standards, and identification of concrete areas for improvement.
Types of missions:
• Internal audits
• Supplier audits
• Initial supplier qualification
• Follow-up audits
With 28 years of experience in quality assurance and regulated environments, I intervene with a pragmatic, independent, and operational approach.
Available for on-site and remote missions in France, Belgium, and Switzerland.
French
Native or bilingual
English
Fluent
Can work on-site
Paris (up to 50km)
Experience
- Audixa ComplianceIndependent Consultant – AuditPHARMACEUTICALS INDUSTRYMarch 2026 - Today (5 months)France
- Proposal and execution of internal audits and supplier audits
- Assessment of regulatory compliance and quality systems
- Identification of deviations, risk analysis, and recommendations for improvement
- Preparation for inspections and certification audits
- Industries pharmaceutiques, dispositifs médicaux, cosmétiquesSenior ConsultantPHARMACEUTICALS INDUSTRYJanuary 2016 - July 2025 (9 years and 6 months)France
- Independent conduct of internal and external audits to assess regulatory compliance, QMS robustness, and process control
- Analysis of deviations, identification of non-conformities, and assessment of associated quality risks
- Documentary audit and assessment of the consistency and effectiveness of the quality system
- Evaluation of the operational application of the QMS and control of critical activities
- Writing of structured, factual, and decision-oriented audit reports
- Industries pharmaceutiques et établissements de santéQuality Assurance Consultant – Qualification & ValidationPHARMACEUTICALS INDUSTRYJanuary 2010 - January 2015 (5 years)
- Qualification of critical facilities, utilities, and equipment (HVAC, utilities, production)
- Validation of manufacturing and cleaning processes – critical parameter analysis
- Management of deviations, quality risks, and CAPA
- Development of qualification strategies and preparation for regulatory audits and inspections
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Education
- ICA Quality Auditor ISO 9001AFNOR Paris2025Auditeur ICA Qualité ISO 9001
- Engineering Degree in Pharmaceutical TechniquesAFNOR Lyon2018Diplôme d'Ingénieur en Techniques Pharmaceutiques