Experience

ExcellGene SA

• Switzerland
• Biotechnology Research
• 1 - 100 Employee

• Head of Quality / QP

  • Mar 2022 - Present



Siegfried Holding AG

• Switzerland
• Pharmaceutical Manufacturing
• 500 - 600 Employee

• Head of Quality Assurance

  • Oct 2015 - Feb 2022

  BASF Pharma Evionnaz was acquired by Siegfried in 2015. Then same production site and description than below. BASF Pharma Evionnaz was acquired by Siegfried in 2015. Then same production site and description than below.



BASF

• Germany
• Chemical Manufacturing
• 700 & Above Employee

• Head of Quality Assurance

  • Jan 2013 - Sep 2015

  API Production site - CMO.Management of Quality Assurance Department (10 QA Managers/Specialists), including (but not limited to) :- Objectives definition and performance indicators/evaluation (KPIs),- API release process owner,- Handling of the product-related quality systems : investigation, change control, CAPAs, PQR, complaints etc.,- Coordination / Lead of customer audits & inspection (FDA, Swissmedic...),- Supplier/contractor management.

• Quality Assurance Manager

  • Dec 2011 - Dec 2012

  Management of all Quality related topics on a portfolio of key products/customers, includes (but not limited to) :- Responsible for the product release process,- Change controls, deviations, CAPAs, investigations follow-up and closure,- Strong customer relationship with quality point of contact,- Quality deputy for projects,- Customer audits and inspection support,- Quality representative for projects (new products) : Quality by Design approach,- Internal audit.



Merck

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Quality Assurance Officer / Quality Auditor

  • Jan 2007 - Nov 2011

  Sterile Drug Product manufacturing site.Quality auditor (2009-2011) :- Quality Audit (suppliers and internal),- Participation of on site regulatory inspections (backroom organization) and corporate audits (direct attendee),- Supplier control (customer requirements, quality agreements, supplier complaint...),- Handling of customer complaint,- Approval of quality documents,- Quality contact for projects.Previously (2007-2009) - Operational Quality Officer :- Investigations on deviations / OOS / OOT,- Quality contact for production and QC support,- Batch manufacturing record review.



Laboratoires d'Armor

• Quality Officer

  • Feb 2006 - Oct 2006

  Batch release.Gap analysis to Cosmetics GMP (ISO 22716)Investigations on customer complaint and deviations. Batch release.Gap analysis to Cosmetics GMP (ISO 22716)Investigations on customer complaint and deviations.



Florame

• Quality Control Analyst

  • Mar 2005 - Jul 2005

  GC/MS Analysis and incoming controls on essential oils GC/MS Analysis and incoming controls on essential oils