Jürgen Rhein

ist offen für Projekte. 🔎

Bis 2023, MES QA-Lead, Merck KGaA, Darmstadt, Germany

Gründau, Deutschland

Fähigkeiten und Kenntnisse

Qualifizierung
Validierung
GAMP
GMP
21 CFR
Part 11
Computer System Validation
CSV
FMEA
Risikoanalyse
Change Management
CAPA
Prozessorganisation
SPC
Projektmanagement
Projektleitung
ISO 9001
ISO 13485
Medical Devices
21 CFR Part 820
Quality System
GMP-Requirements
Qualitätssicherung
QA
Prozessvalidierung
FDA Preparation and Readiness
DIN EN 9120

Werdegang

Berufserfahrung von Jürgen Rhein

  • Bis heute 29 Jahre und 3 Monate, seit 1995

    Gesellschafter und Geschäftsführer

    CPC Consult GmbH

    Qualifizierung von Sondermaschinen und (IT-/SPS-)Anlagen im Pharmabereich und für Zulieferer Projektleitung/-management und Durchführung von Qualifizierungen und Validierungen Zertifizierungsvorbereitung von QM-Projekten Durchführung von Organisationsuntersuchungen und Re-Organisationsprojekten

  • 9 Monate, Okt. 2022 - Juni 2023

    MES QA-Lead

    Merck KGaA, Darmstadt, Germany

  • 10 Monate, Jan. 2022 - Okt. 2022

    QA-Manager for technical Projects

    Merck KGaA, Darmstadt, Germany

  • 1 Jahr und 9 Monate, Jan. 2021 - Sep. 2022

    QA-Manager for technical projects

    Merck Group

    Review and Approval of technical documentation, Review and writing SOP

  • 11 Monate, Feb. 2021 - Dez. 2021

    Project Lead IT & CSV

    Heumann Pharma GmbH & Co. Generica KG

    - Teamleiter - Planung, Einführung, Validierung und Support TrackWise Digital Cloud QMS (Module Complaint, Quality Event, Change Control, Audit Management, Supplier Quality Management) - SysAdmin TrackWise Digital Cloud QMS

  • 4 Monate, Okt. 2020 - Jan. 2021

    Interim Head of QA

    Krewel Meuselbach GmbH

    Self-Inspections, Risk analysis for excipients, SOP-GAP-Analysis, Supplier evaluation

  • 2 Jahre und 5 Monate, Juni 2018 - Okt. 2020

    QA-Manager for technical projects

    Merck KGaA, Darmstadt, Germany

    Local QA for local and global projects

  • 1 Jahr und 3 Monate, Juni 2017 - Aug. 2018

    Requirements Engineer

    BioNTech RNA Pharmaceuticals GmbH

    LIMS, WMS, Interface

  • 1 Jahr, Juni 2016 - Mai 2017

    Consultant Audits & Inspections

    Novartis Pharma GmbH

    - Preparation, Support and Post-Processing of Audits & Inspections - Development and Implementation of a procedure for decontamination in the area of fermentation - Processing of Deviations and CAPA (as Doer, Investigator or Approver)

  • 6 Monate, Dez. 2015 - Mai 2016

    Senior Validation Engineer

    Seidenader Maschinenbau GmbH

    Inspection and Track&Trace Solutions for Pharmaceutical Companies, Code-Reading and -Identification, Serialization - CS-Validation for track&trace software (internal system testing) - Preparation of validation documents for a key customer of Seidenader - Supporting Project Manager and Project Engineer in Validation - Conduct FAT (Factory Acceptance Test) for Serialization and Aggregation Projects

  • 1 Jahr und 3 Monate, Sep. 2014 - Nov. 2015

    QA-Consultant Quality Management

    Laetus GmbH

    - Interim Change Coordinator - Interim Validation Coordinator - Support in Quality Management System (e.g. CAPA, Deviation, NC, Supplier and internal Audits, Risk Management, Verification/Validation) and in R&D (e.g. Design Documents) - Maintain actions out of internal & external audits - Conduct internal audits - Preparation of Standard Operating Procedure (e.g. CAPA, Validation, action list, validation register) - CS-Validation for track&trace software

  • 6 Monate, Juli 2014 - Dez. 2014

    Interim QM-Manager

    Teleflex Medical

    - Processing new and rework older non-conformities (NC), Change Requests (CR), CAPA and Recalls (international) - Optimization of internal processes (NC, CR, CAPA)

  • 1 Jahr und 11 Monate, Jan. 2013 - Nov. 2014

    Interim Quality System Manager (QMB / Auditor

    DANNEWITZ GmbH & Co

    Preparation and recertification (9001, 9120, 13485); Supplier Audits; Internal Audits; Process documents

  • 4 Monate, Juli 2014 - Okt. 2014

    Project manager

    JenaValve Technology GmbH

    - Concept and implementation of a decontamination process for class 3 medical device

  • 1 Jahr, Juli 2013 - Juni 2014

    Interim Manager Complaint Management in Product Quality Assurance

    Boehringer Ingelheim

    Process optimazation and revision SOP Complaint-Management; Supply Chain Management and process support; SOP Training

  • 1 Monat, Juli 2013 - Juli 2013

    GMP-Auditor

    Halfmann Goetsch Partner AG

    Lead-Auditor; Execution of a GMP-Audit (Packaging and blistering of solid dosage forms and dietary supplements) at a pharmaceutical contract manufacturing and logistic company

  • 8 Monate, Nov. 2012 - Juni 2013

    Project-Management-Office and FDA-Preparation

    Novartis Pharma GmbH

    Leading PMO; Coordination and Leadership Steering-Commitee-Meeting and FDA-Preparation; Conduct Self-Audits and Inspections; Complaint- and Deviations-Handling

  • 3 Monate, Dez. 2012 - Feb. 2013

    Coach/Trainer Process Validation

    Activaero GmbH

    Review existing Process Validation process; Establish a new Process Validation structure; Coaching and Training Process Validation

  • 1996 - 2013

    freier Mitarbeiter

    Siemens Building Technologies

    Qualifizierung von Monitoringsystemen gem. GAMP und 21 CFR Part 11 Projektleitung und -management von Qualifizierungsprojekten Inbetriebnahmen von Bus-Kopplungen und DDC-/SPS-Systemen

  • 4 Monate, Mai 2012 - Aug. 2012

    Process Assurance Consultant (FDA-Project)

    Aspen Pharma GmbH, Bad Oldesloe

    Review of internal/external prepared Qualification- and Validiation-Documents of existing equipment according GAMP 5, 21CFR Part 11 and internal Guidelines in preparation of a FDA-Audit

Ausbildung von Jürgen Rhein

  • Europäische Betriebswirtschaftslehre

    Euro-FH Hamburg

Sprachen

  • Deutsch

    -

  • Englisch

    -

Interessen

Kirche des Nazareners - Evangelische Freikirche (im mittleren Kinzigtal)

21 Mio. XING Mitglieder, von A bis Z