GMP & Compliance
Quality oversight and pragmatic compliance across regulated pharmaceutical and biotech environments.
Senior QA & Compliance Expert
Bridging Quality,
Compliance and
Engineering.
Turning complex regulatory and technical requirements into structured, pragmatic and sustainable solutions.
PHARMABIOTECHMEDTECH
CFPortrait 02
to be placed here
to be placed here
QUALITY · CLARITY · DELIVERY
THE VALUE I BRING
I connect the language of quality with the realities of engineering and operations — creating compliance that is robust, clear and built to last.
CORE EXPERTISE
Where quality meets
technical reality.
Focused expertise for complex, highly regulated environments.
Qualification
Lifecycle-focused qualification strategies spanning IQ, OQ and PQ for facilities, utilities and process systems.
Quality Systems
Audit readiness, deviations, CAPA and change control translated into clear, workable quality practice.
Risk & MedTech
A growing MedTech focus grounded in MDR, Design Control, ISO 14971 and ISO 13485 principles.
SELECTED EXPERIENCE
Complex environments.
Clear outcomes.
Representative, anonymised areas of delivery.
QUALITY × ENGINEERING
Infrastructure & utility systems
Quality and qualification leadership for technical systems in regulated manufacturing environments — aligning engineering delivery with GMP expectations.
↗LIFECYCLE COMPLIANCE
Cleanroom & process systems
Structured qualification and compliance support from requirements through verification, handover and continued compliant operation.
↗QUALITY OPERATIONS
Systems that work in practice
Hands-on work across deviations, change control, batch documentation, gap assessments and risk-based methods including FMEA.
↗HOW I WORK
Senior judgement.
Practical delivery.
Good compliance is not bureaucracy. It is a clear framework for making sound decisions, reducing risk and enabling reliable delivery.
My approach combines quality oversight, technical understanding and structured project execution. I work across functions, ask the right questions early and keep solutions proportionate to the real risk.
01 Structured02 Pragmatic03 Sustainable
EDUCATION & CONTINUOUS DEVELOPMENT
Experience, kept
deliberately current.
Executive MBA
Business perspective complementing deep quality and technical experience.
MedTech & risk disciplines
MDR · Design Control · ISO 14971 · ISO 13485
LET'S CONNECT
Complex challenge?
Let's make it clear.
For quality, compliance and engineering challenges across Pharma, Biotech and MedTech.
Email Christian ↗LinkedIn ↗christian@fraguio.ch · LinkedIn