MGMerve G.Pharmaceutical Quality Assurance
ENDE

MERVE G. · CHEMICAL ENGINEER

A clear approach.
A quality mindset.

Pharmaceutical quality assurance, with an engineering perspective. Experience across GMP compliance, quality systems, supplier audits and validation.

Explore my expertiseGet in touch
GMP COMPLIANCEQUALITY SYSTEMSSUPPLIER QUALITYVALIDATION

01 / EXPERTISE

From requirements
to reliable practice.

Connecting technical understanding with a structured approach to pharmaceutical quality.

01

Quality assurance & systems

Experience in quality risk management, change control, customer complaints and product recalls, complemented by an ISO 9001 perspective.

  • Quality risk management
  • Change control
  • Complaints & recalls
  • ISO 9001
02

GMP & supplier quality

Experience in GMP compliance, audits and supplier audits. A focus on clear findings, proportionate follow-up and the evidence behind quality decisions.

  • GMP compliance
  • Audits
  • Supplier audits
  • Risk-based evaluation
03

Validation

Experience in process and cleaning validation, alongside computerized system validation. Connecting process understanding, documented requirements and verification.

  • Process validation
  • Cleaning validation
  • Computerized systems

02 / IN PRACTICE

Making quality
decisions tangible.

Three illustrative scenarios exploring the questions, evidence and reasoning behind a quality decision.

01
SUPPLIER QUALITY

From supplier audit to meaningful follow-up

Connecting a finding, its potential impact and evidence of effective action.

Explore scenario
02
QUALITY SYSTEMS

Seeing the full impact of a change

Evaluating a process change across quality systems, suppliers and validation.

Explore scenario
03
QUALITY ASSURANCE

Turning complaint signals into the right questions

Using recurring observations to define a focused quality investigation.

Explore scenario

These are educational scenarios, not accounts of completed projects or claims of measured results. No employer, product or supplier information is disclosed.

03 / INSIGHTS & REFERENCES

Notes on better practice.

Practical reflections on quality systems, supplier oversight and keeping regulatory knowledge current.

RISK MANAGEMENT

A risk score is the beginning of a discussion

What makes a quality risk assessment useful for a decision?

Read the noteSUPPLIER AUDITS

Closing an action is not the same as demonstrating effectiveness

A practical distinction in supplier audit follow-up.

Read the noteREGULATORY AWARENESS

Reading GMP updates: status before action

A simple routine for separating a new publication from a new applicable requirement.

Read the note
Primary referencesEU GMP · EudraLex Volume 4ICH Q9(R1) · Quality Risk ManagementICH Q10 · Pharmaceutical Quality System

04 / ABOUT

An engineering foundation.
A focus on quality.

I’m Merve G., a chemical engineer with experience in pharmaceutical quality assurance. My background covers GMP compliance, audits and supplier audits, risk management, change control, recalls, customer complaints, process and cleaning validation, computerized system validation, and ISO 9001.

My career focus is on quality assurance and quality systems, as well as supplier quality and GMP auditing, within the German pharmaceutical industry. This portfolio brings those areas together and creates space for practical knowledge beyond a CV.

A structured way to approach quality

  1. 01Understand the process and its quality implications.
  2. 02Connect the risk assessment to the decision.
  3. 03Look for evidence that actions are effective.

05 / CONTACT

Let’s talk
about quality.

For opportunities in pharmaceutical quality assurance, quality systems, supplier quality or GMP auditing, you can reach me directly.

Request my CV