GMP-/Medical Device Consultant

2/2021 – 12/2021

GAMP 5, 21 CFR Part 11, QSReg (Part 820), ICH, Ph.EU

- Teamlead IT & CSV
- Planning, Implementation, Validation and Support TrackWise Digital Cloud QMS (modules Complaint, Quality Event, Change Control, Audit Management, Supplier Quality Management)
- SysAdmin TrackWise Digital Cloud QMS
- Responsibility for Validation for IT&CSV

Systemadministrator, Management-Informationssysteme, Validierungsingenieur

10/2020 – 1/2021

GAMP 5, 21 CFR Part 11, QSReg (Part 820), ICH, Ph.EU, 13485

- Head of Quality Assurrance department (5 employees)
- Planning and implementation of self-inspection (e.g. Production, Quality Control, IT)
- Establishing of new process in the areas of Supplier and RAW-Material/APIs and auxiliary material qualification
- Audit preparation and follow-ups (Implementation of the formalized GMP-risk assessment for excipients of medicinal products for human use)
- Participation in the planning and implementation of new software-based systems (e.g. Document Management System, Chromeleon)
- SOP-System GAP-Check

Qualitätsmanager, Risikoanalyse

5/2018 – 10/2020

Quality Assurance
- Acting as local QA in local and global IT-projects and -system projects (e.g. MES, KDM, SAP, LIMS)
- Acting as the responsible QA for Laboratory Equipment and Systems incl. CSV (e.g. Prep-Ash, environmental monitoring, freezer, HPLC,…)
- QA for Change Control and Deviation in TrackWise as Author and Approver
- Testing and approval of qualification documents from a quality assurance perspective
- Inspection and release of calibration and maintenance documents from a quality assurance perspective
- Execution of periodic review and creation or revision of SOP/work instructions for GMP-regulated IT systems and related operational processes (e.g. CSV-SOP)

Manufacturing Execution Systems, Gute Laborpraxis (GLP), Technisches Qualitätsmanagement / QS / QA, Qualitätsmanager, Good Manufacturing Practices

5/2017 – 8/2018

GAMP 5, CFR Part 11, QSReg (Part 820), ICH
- Preparation of requirements for
o a LIMS in Quality Control
o Stability
o Environmental Monitoring
o Interfaces in IT
- Preparation and Documentation of process operation
- Processing of Deviations, Changes and CAPA (as Doer, Investigator or Approver)
- Validation Lead QC Module Stability and Environmental Monitoring

Validierungsingenieur, Gute Laborpraxis (GLP), Anforderungsspezifikationen

6/2016 – 5/2017

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)

Projekt-Qualitätssicherung

12/2015 – 5/2016

- 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

Projekt-Qualitätssicherung

9/2014 – 11/2015

- 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

Projekt-Qualitätssicherung

7/2014 – 12/2014

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

Projekt-Qualitätssicherung

7/2014 – 10/2014

Concept and implementation of a decontamination process

Projekt-Qualitätssicherung

7/2013 – 7/2013

GAMP 5, 21 CFR Part 11, QSReg (Part 820)

6/2013 – 6/2014

GAMP 5, 21 CFR Part 11, QSReg (Part 820), Complaint Handling, Process optimization and revision of SOP Complaint Handling, Training

FMECA (Failure Mode and Effects and Criticality Analysis)

1/2013 – 11/2014

GAMP 5, 21 CFR Part 11, ISO 9001, ISO 13485, ISO 14971,
MDD 93/42/EWG, EN 9120 (Luft- und Raumfahrtindustrie)

Supply-Chain-Management (SCM)

12/2012 – 2/2013

GAMP 5, 21 CFR Part 11, ISO 9001, ISO 13485, ISO 14971, MDD 93/42/EWG

11/2012 – 6/2013

- Leading Project-Management-Office and interface to Global PMO
- Coordination and Leadership Steering-Commitee-Meetings
- Coordination and Leadership FDA-Preparation Core-Team
- Coordination Strategic Backoffice
- Coordination Rehearsal-Sessions (with Quantic)
- Processing and Tracking Site-Quality-Risk-Assessment
- Preparation and Contribution in external Quality-Audits (Supplier and internal global compliance department)
- Conduct Self-Inspections
- Aktive cooperation in improving the quality and processes in clinical samples
- Cooperation in Complaint-/Deviation-Handling (internal cerified QA-Investigator)
- Sucessful FDA-Audit in May 2013 (without observations)

Projekt-Qualitätssicherung

11/2012 – 6/2013

GAMP 5, 21 CFR Part 11, QSReg (Part 820)

5/2012 – 8/2012

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
Processing and review open-issues regarding to Qualifications and Validations (NC-/CAPA-Handling)
Planning and preparation Process-/Equipment FMEAs and Cleaning-Validations

3/2011 – 4/2012

Review of all internal/external prepared Qualification and Validiationdocuments according GAMP 5,
21CFR Part 11 and internal Guidelines in the capacity of Validation Manager
Processing and review open-issues regarding to Qualifications and Validations (NC-/CAPA-Handling)
Time-/Ressources- and Issue-Planning and - monitoring of all Q-/V-Aktivities in Qualitymanagement- Department
Planning and preparation Process-/Equipment FMEAs and Cleaning-Validations

11/2010 – 2/2012

GMP-Auditor (Consultant) in QA-Supplier Department
Work performed:
Supplier Audits, Supplier Evaluation, Evaluating and supporting Equiment-Qualification and Process-Validation at the suppliers
Screening, assessment and revision of quality management documents (e.g. quality manual, SOP, Templates, quality agreements) acc. to ISO9001, QSR and 13485
Screening, assessment and adaptation of processes acc. to ISO9001, QSR and 13485

4/2010 – 9/2010

Process- and CSV-Validation
Planning and implementation of a Process and Product Validation
for a new medical device product
acc. ISO 13485 and QSR 820
Managing of a process validation team of four individuals
Preparation Design- and Process-FMEA
Review CSV-Project
Execution of DoE’s, inter alia laser technology and cleaning and drying
Supplier Audits in Germany and Switzerland

6/2009 – 3/2010

Head of Regulatory and Quality Affairs
Quality System Manager 13485 and 9001
Software and Process Validation (QSReg, Part 11, GAMP 5)
Complaint Handling and CAPA-Management