Expertise
What I deliver.
Four areas where I add value from the first week, in GMP production, QC laboratories and quality assurance.
Qualification and validation
Qualification of equipment, utilities, facilities and laboratory systems, written so it is clear to execute and holds up under inspection.
Quality assurance
Review and approval of SOPs, protocols and reports, deviations investigated to a real root cause, CAPAs and change requests followed to closure.
Laboratory systems and data integrity
LIMS implementation, data migration, templates and automated review, audit trail review and user training as site SME.
Readiness and improvement
Laboratories and records brought to inspection readiness, risk assessments done before execution, and manual steps removed where they add errors instead of value.
Dosage forms
Ways to work together.
Permanent role
Senior QA, QC or validation positions in pharmaceutical and biotech manufacturing.
Contract or project
Qualification, CSV and readiness projects with a clear scope and timeline.
On site in Switzerland
Based in Visp, Valais, with a Swiss permit C. Open to on site work.