Ing. Hazem Alzarie
DEEN

Qualification Engineer · Validation Expert · Consultant

Hazem Alzarie

I qualify equipment and validate processes for the medical and pharmaceutical industry. From the first DQ to the completed PQ. Self-employed since 2023, with over 5 years of experience.

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Portrait of Hazem Alzarie, qualification engineer
Fig. 01Qualification Engineer

Numbers that speak for themselves

5+
Years
Qualification Engineer
3+
Years
Automation Engineering
2023
since
Self-employed
GxP
Pharma
Medical Technology

§ 01 Profile

Qualification is not a paper tiger, but patient safety in practice.

I am Hazem Alzarie, a qualification engineer with a Master's in Automation Engineering and a Bachelor's in Electrical Engineering. For over 5 years I have qualified and validated equipment and processes in the medical, pharmaceutical and automotive industries.

Focus: GxP-compliant equipment qualification (DQ / IQ / OQ / PQ), process and software validation, change controls and CAPA management. Self-employed since 2023, I speak the language of regulators as fluently as that of the production floor.

What you get: structured documentation, on-time approvals and a partner who doesn't just know regulatory requirements but lives them in practice.

GxP-compliant

●

DQ, IQ, OQ, PQ. Complete qualification documentation in line with applicable regulations.

Interdisciplinary

●

Automation meets qualification: I speak with engineers, regulators and QA teams.

Independent

●

A freelance engineer since 2023. Flexible, reliable and focused on what matters.

Modern production hall with precise robotic lines
Fig. 02 · Pharmaceutical Production
KI-generiert

§ 02 Services

Six services for reliable qualification.

N° 01

Equipment Qualification DQ / IQ / OQ / PQ

Complete qualification of production and packaging equipment to GxP requirements. From design qualification to performance qualification.

  • +Design Qualification (DQ)
  • +Installation Qualification (IQ)
  • +Operational Qualification (OQ)
  • +Performance Qualification (PQ)
N° 02

Process Validation

Validation of manufacturing and packaging processes in the pharmaceutical and medical device industry. Preparation of all related validation documents.

  • +Validation plan & report
  • +Statistical process analysis
  • +Test method validation
  • +Revalidation & reviews
N° 03

Software Validation (CSV)

Computerized system validation to GAMP 5 and 21 CFR Part 11. From risk classification to acceptance test protocol.

  • +GAMP 5 / 21 CFR Part 11
  • +Risk classification
  • +URS / FS / DS / IQ / OQ
  • +Audit trail reviews
N° 04

Change Control and CAPA

Structured handling of changes and deviations. Root cause analysis, risk assessment and effectiveness checks of the measures taken.

  • +Change control management
  • +CAPA handling
  • +Deviation management
  • +Effectiveness checks
N° 05

SOP Authoring and Review

Authoring, review and updating of standard operating procedures (SOPs) in line with regulatory requirements and internal QM guidelines.

  • +SOP authoring & review
  • +Training records
  • +Version control
  • +GMP-compliant language
N° 06

Risk Analysis (PFMEA) & Project Management

Process FMEA, risk assessments and stakeholder facilitation in interdisciplinary validation projects. KPI maintenance and monitoring.

  • +PFMEA facilitation
  • +Risk-based approach
  • +Project control
  • +KPI monitoring

§ 03 Career

From engineer to qualification expert hands-on and regulatory-savvy.

From academic foundations to today's independent practice, read from top to bottom.

  1. 1Degree

    B. Eng. Electrical Engineering

    University · Foundations of automation engineering
  2. 2Degree

    M. Sc. Automation Engineering

    University · Focus on control engineering & systems
  3. 3~ 3 years

    Automation Engineer

    Electrical & automotive industry · Germany

    Design and commissioning of automated production systems. Interface between development, production and quality assurance.

    AutomationPLCAutomotive
  4. 4~ 5 years

    Qualification Engineer (employed)

    Medical & pharmaceutical industry · Germany

    Execution of equipment qualifications and process validations in vaccine production and packaging. Coordination of qualification projects, stakeholder facilitation and KPI maintenance.

    IQ / OQ / PQPharmaVaccine Production
  5. 52023 to today
    current

    Independent Qualification Engineer

    Freelance · Germany

    Equipment qualifications (DQ/IQ/OQ/PQ), process and software validation as well as change control and CAPA management for clients in the medical and pharmaceutical industry. Authoring and review of SOPs.

    QualificationValidationGxPCSV

§ 04 Contact

Let's talk about your next project.

A no-obligation 30-minute call is enough to clarify whether and how I can help. Reply within 24 hours on business days.

Location

Schwäbisch Hall
Nationwide & DACH region