About me

Cavidan
Şentürk

Biotechnology GMP & Quality Assurance Consultant — specializing in greenfield facility setup, end-to-end quality systems and validation.

Work with me See key projects
Cavidan Şentürk
GMP Lead AuditorExemplar Global certified
20+years in pharmaceutical & biotech QA
~300equipment & utilities qualified
3countries of international projects
QPQualified Person & QA Manager

With over 20 years of experience as a Quality Assurance Manager and Qualified Person (QP) in the pharmaceutical and biotechnology industries, I drive all quality operations from R&D to commercial manufacturing with a strategic approach.

I have designed and established complete Quality Management Systems from scratch for biotechnology manufacturing facilities, Quality Control (QC) and R&D laboratories — overseeing commissioning, validation and qualification, quality management and regulatory audit readiness.

My core focus is end-to-end GMP compliance, commissioning and operational quality systems for pharmaceutical and biotech manufacturing.

  • Validation & qualification
  • CAPA
  • OOS
  • Deviations
  • Change control
  • Risk management (ICH Q9)
  • Commissioning
  • Audit readiness
  • Qualified Person (QP)
Key projects & milestones

Two decades,
built in the field.

  1. Vaccine

    VLP COVID-19 vaccine production

    Phase 1 & Phase 2 manufacturing, recognised with a Regulatory & GMP Compliance Project Award.

  2. Germany

    Bioreactor, TFF & MFCS FAT

    Factory acceptance testing of bioreactor, Tangential Flow Filtration and MFCS systems.

  3. Korea

    Technology transfer

    Transfer of process and analytical know-how between sites.

  4. Canada

    GMP inspection

    GMP inspection of a biotechnology manufacturing facility.

  5. ~300 equipment

    Qualification & validation

    Manufacturing, QC and R&D equipment and utilities (HVAC, PW, WFI, gas distribution); computerized systems (BMS, SCADA, MFCS, Empower).

  6. Greenfield

    Quality system setup

    Bilingual and English-compliant QMS developed from scratch for biotechnology R&D, QC laboratories and manufacturing facilities.

Credentials

Certifications & recognition.

Exemplar Global

GMP Lead Auditor

Approved Pharmaceutical & Biotechnology GMP Lead Auditor · 2022 · No. QALA-EXE-20221126

Quality management

ISO 9001 Internal Auditor

Certified internal auditor for quality management systems.

ECA Academy, Germany

GMP for Biopharmaceuticals

Specialised training in GMP for biopharmaceutical manufacturing.

Regulatory & GMP Compliance

Project Award

Awarded 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.

Get in touch