27.10.2026 aktualisiert
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Pharma QA & Validation + AI Engineering | GMP, CQV, CSV, ML/LLM | Swiss Life Sciences Experts
Basel, Schweiz
Deutschland +2
MSc Pharmaceutical Quality Assurance & Regulation (DIT Dublin), Diploma in Biology (Univ. Freiburg)info: Deutschland, Österreich, Schweiz
Skills
BiopharmazeutikaPharma-EngineeringIq/oq/pqGXP
Quality Assurance leader, Lead Auditor and pharma engineer with 20 years in the life science industry, including 10 years as an independent GMP consultant (SQPS – Swiss Quality & Process Service). I support biotech, pharmaceutical and CMO clients across Switzerland and Germany, from development to commercial manufacturing.
Core expertise
- Quality Assurance & QMS: building, improving and harmonizing quality management systems, SOPs, batch records, document and records management
- Validation & Qualification (CQV): process validation, cleaning validation, thermal and sterilization validation (moist heat), media fills, equipment qualification (IQ/OQ/PQ) per ISPE guidelines
- Computer System Validation (CSV): GAMP 5, 21 CFR Part 11, SCADA systems
- Deviation, CAPA, change control, failure investigation and root cause analysis
- Quality Risk Management: risk assessment, FMEA, QbD, ICH Q8–Q10
- Inspection readiness: FDA, Swissmedic and EMA inspections, playbooks, audit preparation
- Third-party and supplier management: CMO oversight, supplier qualification, quality agreements
- Auditing: certified ISO 9001 Lead Auditor, ISO 13485 internal audits
- Single-use systems and clean room / HVAC qualification
- Regulatory: CTD section review, EMA biosimilar regulation, combination products
Industries and products
Biopharmaceuticals and mAbs (2,000–12,500 L scale), mRNA, vaccines, antibody-drug conjugates and highly potent compounds, sterile and non-sterile dosage forms, small-molecule APIs, diagnostics, veterinary products and combination products.
Selected experience
- QA Lead for a single-use project and site-wide clean room QA SME at a multinational mAb CMO
- Interim Head Quality Third-Parties at an mRNA pioneer
- QA Lead for Qualification on a CHF 350M bioconjugation plant extension, including a passed Swissmedic inspection and FDA readiness
- CSV and qualification support on a €1.2B biopharmaceutical project
- Team Lead Validation (sterile, galenic and API products) and Team Lead Process Validation at Roche Basel
- Process validation for oncology mAbs and new chemical synthesis routes
Education & certifications
MSc Pharmaceutical Quality Assurance & Regulation (Dublin Institute of Technology), Diploma in Biology (University of Freiburg / Max Planck Institute for Immunobiology), ISO 9001 Lead Auditor, GAMP 5 / Part 11, PDA Process Validation and QbD, Design of Experiments, Minitab statistical process monitoring. Published author on European biosimilar regulation.
Languages: German (native), English (fluent), French (conversational), Arabic (basic). Based in Basel, available remote or on-site.
Erfahrung
Berufserfahrungmehr als 10 Jahre
Freelancer seit2016
Sprachen
ArabischGrundkenntnisseDeutschMutterspracheEnglischverhandlungssicherFranzösischgut
Projekthistorie
- Provide strategic QA guidance and policies for a single-use systems project (CQV), embedding it into the existing QMS
- Site-wide QA SME for clean rooms
- Inspection readiness and response to inspection findings
- Review and approve QMS documentation: plans, reports, deviations, CAPAs, change controls, VMP
- Train, onboard and mentor junior QA colleagues and permanent staff