Cavidan Şentürk
Biotechnology GMP & Quality Assurance Consultant — GMP systems setup, validation and quality operations.
More than 20 years of Quality Assurance experience in the pharmaceutical and biotechnology industries.
I have designed and built complete Quality Management Systems from scratch for commercial manufacturing facilities and QC laboratories — covering validation and qualification, CAPA, OOS, deviations, change control, risk management and regulatory audit readiness.
My focus is biotechnology: end-to-end GMP readiness, commissioning and operational quality systems for advanced biotech manufacturing.
Key projects & milestones.
- GermanyFAT of bioreactor, TFF (Tangential Flow Filtration) and MFCS systems
- KoreaTechnology transfer
- TİTCKGMP inspection of a biotechnology manufacturing facility
- VaccineVLP COVID-19 vaccine production, Phase 1 & Phase 2
- ~300 systemsQualification of production, QC and R&D equipment and utilities (HVAC, PW, WFI, gas distribution) and computerized system validation (BMS, SCADA, MFCS, Empower)
- From scratchQuality systems established in English for biotechnology R&D, QC and production facilities
Certifications & recognition.
GMP Lead Auditor
Exemplar Global Approved Pharmaceutical & Biotechnology GMP Lead Auditor. Certified 2022, No. QALA-EXE-20221126.
ISO 9001 Internal Auditor
Certified internal auditor for quality management systems.
GMP for Biopharmaceuticals
ECA Academy training, Germany.
Project Award
Regulatory & GMP Compliance Project Award for the VLP vaccine project.
Ready for your next inspection?
Let's talk about your facility, your timeline and where your quality system stands today.