Omschrijving

Senior Quality Assurance and CQV Lead Consultant with over 15 years of experience in pharmaceutical and healthcare manufacturing environments.

I support companies in managing complex quality and validation challenges, including change control, CAPA, audit readiness, and multi-site QMS governance.

I have strong experience working with CMOs and cross-functional teams, ensuring GMP compliance and operational readiness across validation lifecycle (IQ/OQ/PQ).

My expertise includes TrackWise investigations, risk-based validation, training compliance, and quality system harmonization.

I am particularly effective in high-pressure environments requiring autonomy, structured problem-solving, and stakeholder coordination.

📍 Available for freelance assignments in France and Switzerland

📅 Immediate or short notice availability

Branche-expertise

Talen

Frans
Tweetalig / moedertaal
Engels
Tweetalig / moedertaal
Duits
Beperkte professionele capaciteit

Voorkeuren voor werkplek

Kan op locatie werken

Morteau (tot 50km), Lyon (tot 50km), Paris (tot 50km), Bordeaux (tot 50km)

Techfirm
Senior QA/CQV Consulting Lead
oktober 2023 - april 2026 (2 jaren en 6 maanden)
• • GMP compliance, Quality Systems (CAPA / PCR) and documentation management
• • Leadership of QA departments and multi-site quality oversight
• • Equipment, process & cleaning validation (CIP/SIP – IQ/OQ/PQ)
• • Process improvement, internal audits, inspection readiness and assessments
• • Paperless validation (Kneat) and supplier quality management
• • Risk management: FMEA, Fishbone, DMAIC
• • Lead Discipline C&Q for laboratory, USP, and DSP equipment
• • Pharmaceutical operations supervision and batch record review
• • Leadership of QA teams with monthly training evaluations across multiple sites
• • QMS performance and quality KPI reporting to senior management
TrackWise Investigation CAPA Management GMP Compliance Regulatory Inspection Readiness Commissioning, Qualification & Validation (CQV) MultiSite CQV Leadership Paperless Validation (Kneat)
Lonza (Visp)
CQV Lead
oktober 2023 - februari 2026 (2 jaren en 4 maanden)
Led and oversaw CQV activities, Lead Investigator for TrackWise events, monthly training management across Stein, Basel and Visp. GMP compliance and continuous improvement. Front-line paperless validation across multiple projects. Implementation of remediation plans including P&ID review and approval. CSV qualification of laboratory equipment. Successful qualification delivered on schedule. Front-line protocol redaction for laboratory, USP & DSP equipment in cooperation with SMEs. Supplier IOQ follow-up and planning management. GMP Risk Analysis execution and GAP analyses via traceability matrix. Full validation of medical device assembly line (gears, ultrasonic welding, torque check). New medical device implementation (hyaluronic filler) – FMEA, pFMEA, VMP, PQ for filling & stoppering machine. Full site gap analysis ISO 22716 / FDA OTC. Preparation, execution, documentation and remediation plan.
Biogen (Luterbach)
Quality Assurance Associate
september 2022 - oktober 2023 (1 jaar en 1 maand)
– Biopharmaceutical Manufacturing
Switzerland | 2023
Led quality oversight of validation activities and remediation programs.
Improved QMS compliance and documentation practices.
Supported audit readiness and inspection activities.