Recommended expert

Amara El Madak

Qualification Engineer

Amara El Madak
Flörsheim am Main, Germany

Experience

Mar 2024 - Present
1 year 11 months
Schwäbisch Hall, Germany

Qualification Engineer

Optima Pharma GmbH

  • Qualification of filling lines
  • Preparation of IQ, OQ, PQ documents and reports
  • Execution of FAT and SAT
  • Alarm lists: create and perform tests
  • Preparation of GMP-compliant documentation (qualification plan, URS, risk analysis, IQ, OQ, PQ and qualification report)
Jul 2023 - Feb 2024
8 months
Austria

Qualification Engineer

Takeda Austria

  • Qualification of laboratory equipment (Raman spectrometer, image compare, ELISA reader)
  • Preparation of GMP-compliant documentation (qualification plan, URS, risk analysis, IQ, OQ, PQ and qualification report)
Oct 2022 - Jun 2023
9 months
Lich, Germany

Qualification Engineer

BAG-Helthcare

  • Qualification, requalification and periodic review of various systems: pure steam generator, compressed air generation, sterilizer ICOS, incubators, refrigerators, autoclave Sauter (temperature mapping), freeze-dryer, filling machine, hot air tunnel ST4, cleanroom ventilation system, sampling cabinet, monitoring of pharmaceutical production, WFI and HPW system, isolator
  • Sterilization of products in cleanroom class A and B
Jan 2022 - Sep 2022
9 months
Sempach, Switzerland

CSV Engineer

Bbraun Sempach Schweiz

  • Independent planning and execution of risk-based validation of computerized systems in the OT/IT field for drug and medical device production
  • Ensuring complete GxP-compliant documentation for the entire lifecycle of computerized systems according to GAMP 5 (changes, GAMP categorization, data integrity, risk analyses, traceability, specifications, test planning, test execution, reviews and deviations)
  • Specification of test cases, test prerequisites, test data, test scripts, test acceptance criteria as well as execution and documentation of these test cases
  • Consulting and support for process owners in connection with projects, commissioning and maintenance of GxP-relevant computerized systems
  • Participation in the continuous improvement of digitization and data integrity
  • Creation of FAT and SAT for a PLS system
  • Support as a validation expert in defining the validation strategy, executing validation, managing deviations, implementing CAPA measures and changes, and identifying possible solutions
  • Conducting training in the validation of computerized systems
  • Close coordination and collaboration with stakeholders on site and globally
  • Compilation and GMP evaluation of production data in the aseptic filling area, creation and follow-up of change control requests
Sep 2021 - Dec 2021
4 months
Bern, Switzerland

Qualification Engineer

CSL Behring GmbH

  • Cleanroom qualifications
  • Review of calibration certificates performed by external service providers
  • Review of qualification status of equipment
  • Checking ventilation logs
  • Assistance with revalidations of production equipment such as autoclaves, sterilization tunnels
  • Revision of documents and procedures
  • Review of qualification documentation for equipment (e.g. refrigerators, benchtop instruments, centrifuges, HPLC (method transfer))
May 2021 - Aug 2021
4 months

Project Engineer

Lonza GmbH

  • Organization, coordination, execution and enforcement of qualifications
  • Validations and routine introductions of complex systems under GMP in microbiology quality control and possibly involved sites
  • Clarifications and collaboration with QC Microbiology internally, with QA of various departments, with production sites and external companies
  • Consulting and theoretical and practical support for several system qualifications in USP/EP matters
  • Consulting and theoretical and practical support for multiple qualifications and validations of complex computer-controlled robotic systems under GMP in QC Microbiology
  • Change control and CAPA processing (Trackwise)
Nov 2020 - Apr 2021
6 months
Schwalbach am Taunus, Germany

Project Engineer

Siemens Healthcare Diagnostics Products GmbH

  • Checking the operability of software modules of the BNII V2.7 software on Mac OS 10.15.6 to ensure the basic functionality of the software for design verification
  • Planning and executing the developed tests
  • Evaluating and documenting the test results in the Imbus TestBench tool
  • Performing design verification of the BNII V2.7 software using test specifications and executing them on the BNII diagnostic system
  • Creating test specifications and applying existing ones in the Imbus TestBench test management tool and the SBM defect tracking tool
Mar 2020 - Oct 2020
8 months
Marburg, Germany

Qualification Engineer

CSL Behring GmbH

  • Qualification of equipment as part of SAT/FAT
  • Method validation (HPLC)
  • Qualification of a monitoring system: creating GMP-compliant documentation
  • Qualification of a packaging line in the sterile area
  • Method validation
Sep 2019 - Feb 2020
6 months

Validation Engineer

Lohmann & Rauscher GmbH

  • Commissioning of image processing systems on converting lines
  • Process validation of a converting line
  • Qualification of measuring equipment & process validation
  • Validation of computer systems according to GAMP
  • Software validation in the GMP environment
  • Commissioning of a new process control system
  • Qualification of the associated process control systems
Aug 2018 - Aug 2019
1 year 1 month
Munich, Germany

Validation Engineer

Formycon AG

  • Qualification coordinator: training employees on key qualification documents
  • Reviewing qualification documents on behalf of the QA department
  • Qualification of analytical instruments (HPLCs, UPLC, mass spectrometers, Cary 8454 photometer, UV-VIS spectrometer, ELISA reader, NIR spectrometer, centrifuges) and evaluation
  • Data integrity, CSV and user management configurations
  • Creating a master plan and a gap analysis
  • Qualification of freezers and refrigerators with mapping
  • Document support for requalification of equipment, systems and computer systems
  • Analysis of changes to equipment and systems
  • Discussing and tracking deviations
  • Creating and updating technical documentation, procedures and protocols
  • Method validation of analytical equipment
Jan 2018 - Jul 2018
7 months
Vienna, Austria

Validation Engineer

Shire AG

  • Qualification of various analytical instruments
  • Documentation support for requalification of equipment, systems and computer programs
  • Analysis of changes to equipment (BioTek Cytation5, HPLCs, photometers, centrifuges, filtration system)
  • Discussion and tracking of deviations
  • Creation and update of technical documentation, instructions and protocols
  • Data Integrity Assessment
  • Method validation
Mar 2017 - Dec 2017
10 months
Hettlingen, Switzerland

Validation Engineer

Akorn AG

  • Qualification of a sterile filling line (qualification and GMP-compliant documentation of the system and existing and new equipment)
  • Data Integrity project
  • Qualification of various analytical instruments (NIR spectrometers, HPLC, UPLC, viscometer, titration devices, centrifuges, drying oven, vacuum drying oven, turbidity meter, density meter, freezer, UV-VIS photometer, analytical, top-loading and microbalances)
  • Cleaning validation: pipette washer, cleaning and disinfection machine (with TOC measurements) and CIP stations
  • Documentation of qualification steps DQ, IQ, OQ, PQ plans, reports as well as device SOP creation and change control
Aug 2011 - Feb 2017
5 years 7 months
Schwalbach am Taunus, Germany

Test Engineer

Siemens Healthcare Diagnostics Products GmbH

  • System testing of diagnostic devices in a lab environment
  • Use of given test procedures (assessment of successful test or deviations)
  • Documentation of test execution and deviation/error observation in a test database and log file backup
  • Modification of written test procedures based on specification changes
  • Creation of new test procedures according to software specification
  • Test execution for various blood test systems (BNProSpec, Royal, BCSXP…)
  • Testing fluid systems (pumps), hardware and software
Sep 2009 - Jul 2011
1 year 11 months
Melsungen, Germany

Validation Engineer

Bbraun Melsungen

  • Validation and qualification
  • Preparation and writing of qualification documents (user requirements, DQ, IQ, OQ, PQ and alarm acceptance tests)
  • Risk assessment for lab systems (HPLCs, GCs, AAS etc.); qualification and documentation for systems: vessels
  • Cleaning validation: CIP stations
  • Ultra filtration system, compressed air distribution system, pure steam distribution system, purified water for production, thermal decontamination, lab equipment, autoclaves, sterilizers, laminar flow
Apr 2008 - Sep 2009
1 year 6 months
Ingelheim am Rhein, Germany

Validation Engineer

Boehringer Ingelheim

  • Validation of a blister line (EAS 420, Klöckner-Pentapack)
  • Packaging of medicines in blister packs
  • Team coordinator across qualification stages and phases (DQ, IQ, OQ, PQ) for system and product validation
  • Qualification of laminar flow units and cooling equipment
  • Writing validation plans, URS (user requirement specs), FS (functional specs) and risk analysis for various lab devices (HPLCs, GCs etc.)
  • Writing, execution and evaluation of qualification protocols for various systems in pharmaceuticals
  • Writing and resolution of technical deviations
  • Writing and summarizing qualification reports and tests
Aug 2004 - Aug 2007
3 years 1 month
Essen, Germany

Graduate Engineer in Chemical Engineering

BEC Bellenberg Engineering & Consulting

  • Designing a marketing strategy for complex technical products
  • Actively contributing to the creation of requirement and specification documents
  • Planning, conceptualizing, and constructing process engineering plants
  • Preparing technical proposals from the planning phase to customer acceptance in close coordination with sales
Jan 1997 - Jul 2000
3 years 7 months
Dortmund, Germany

Student Assistant

Elmos AG

  • Supporting an engineering team with project execution
  • Creating CAD drawings
  • Measuring particles in a cleanroom
  • Optimizing an exhaust air system

Summary

challenging range of tasks

Skills

  • Ms Office 2000 (Very Good Knowledge)
  • Auto Cad (Very Good Knowledge)
  • Inventor6
  • Aspen Plus
  • Visio Technical
  • Html
  • Javascript
  • Filtration Technology
  • Materials Engineering
  • Mechanical Process Engineering
  • Plant Engineering
  • Mixing Technology
  • Thermal Process Engineering
  • Industrial Chemistry
  • Analytical Chemistry
  • Inorganic Chemistry
  • Chemical Analysis And Measurement Methods
  • Chemical Process Engineering
  • Laboratory Work
  • Laboratory Technology
  • International Pharmaceutical Standards (E.g. Glp, Gmp)
  • Pharmaceutical Technology
  • Production Planning
  • Quality Inspection
  • Quality Assurance
  • Plant Design (Utilities, Process Engineering)
  • Photovoltaics
  • Environmental Analysis
  • Experiment Execution And Evaluation
  • Process Analytics
  • Project Management
  • Waste Management

Languages

Arabic
Native
German
Advanced
English
Advanced
French
Advanced

Education

Mar 1994 - Aug 2001

University of Dortmund

Diploma in Engineering · Chemical Engineering · Dortmund, Germany

Sep 1988 - Jun 1992

Bouchuaib Doukkali University, Morocco

Diploma in Chemistry · Chemistry · El Jadida, Morocco

Certifications & licenses

Certificate in Automation Technology

URS Washington Division

Validation Officer

Concept Heidelberg

Energy Consultant for Renewable Energies

WBS Training Dortmund

Industrial Specialist in CAD Technology

RAG Bildung | Dortmund, North Rhine-Westphalia

Trainee Program teco

Institut für Berufliche Bildung GmbH (IBB) | Bottrop, North Rhine-Westphalia

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