Jürgen Rhein
Bis 2023, MES QA-Lead, Merck KGaA, Darmstadt, Germany
Gründau, Deutschland
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
Review and Approval of technical documentation, Review and writing SOP
- 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
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
- 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
- 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 IngelheimProcess 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
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
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Englisch
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