Senior Consultant; Interim Management-, Integration- und M&A-Support

3/2019 – 12/2020

- Project Coordinator:
o Confirm Due Diligence Results and asses the State of
Compliance of the Quality System versus Internal (Corporate) and
Regulatory Standards (ISO, FDA, etc.)
o Close reporting to local Core Team Leads and global M&A-
Leader
o Prepare Manufacturing Transfer from Israel to European Sites of
the acquiring Corporation
- Project Support:
o Audit existing procedures and documents to the standards and
report non-conformances and findings (both current state and
retrospectively):
▪ Analyzing of Audit- and Inspection reports (Internal /
External), NC/CAPA-Files, Complaints and Complaint
Handling, Maintenance Reports, Monitoring Data,
Trainings, etc.
▪ Perform CAPA verification of effectiveness and add
activities as necessary.
▪ Batch record review
o Update the Manufacturing- and Quality System to meet the
Corporate Standards
o Update the Health and Safety System to meet local, international
and Corporate Requirements
o Update the Complaint Handling System to reduce the runtime and
ensure a compliant communication to the involved authorities
o Make recommendations to achieve compliance where shortfalls
are found and identify improvement potentials, which increase the
productivity and efficiency of manufacturing and facility and
operational practices.
o Training – Support:
▪ FDA Preparation (1st time FDA-Audit in the Company)
▪ Support during the FDA inspection
▪ Thorough understanding of GMP and GCP (Good Clinical
Practices) guidelines.
▪ Consultancy and guidance of all employees regarding
Risk Assessment, Risk Analysis, Maintenance, NCR,
CAPA, Complaint-Handling, etc
▪ GCP, GVP, GMP, cGMP, GDP etc.
o Planning, implementing, follow up projects of
▪ Pest Control
▪ Fatigue Testing
▪ Preventive Maintenance
▪ Launching Product in the US

Lieferantenmanagement (allg.), Gefahrstoffmanagment, Gute Klinische Praxis, Softwaredokumentation, Analysen der Lieferketten, Medizintechnik, Auditor, Compliance management, Good Manufacturing Practices, Installation / Montage / Wartung (allg.), Continuous Integration, Produktmanagement, Projektmanagement - Vorstudien / Machbarkeitsstudien, Prozessmanagement, Qualitätsmanagement (allg.), Qualitätsplanung, Regulatory Affairs, Technisches Testmanagement / Testkoordination

10/2016 – 2/2019

- Project Coordinator:
o Coordinate the Manufacturing Transfer during Site Closure with
local (Austria), European (Switzerland, Germany) and Global
(U.S.A.) Sites and Leaders
o Coordinate the structured Archiving of all Manufacturing- and
Quality related Documents and Records into a Swiss Archive
o Tracking of Deadlines and Meeting with local and corporate
Management
- Project Support:
o Support ongoing Product- / Manufacturing Transfer activities to
ensure the full compliance (internal and external requirements)
until full closure
o Taking over continuously more activities for continuously reducing
internal employees:
▪ Quality Management,
▪ Complaint Handling,
▪ CAPA-Management,
▪ EHS-Management and
▪ Doc. Control incl. Record Management and Archiving
o Checking all the relevant internal and supplier related documents
against former Audit-Findings to ensure full compliance during
ongoing external audits until site-closure
o Prepare and Lead Quality related Meetings:
▪ Monthly Management Reviews
▪ Ongoing NC/CAPA- and Complaint-Status Meeting
o Coordination and Support of ongoing Activities incl. newly found
Complaints, Manufacturing Investigations and Corrective /
Preventive Activities
o Audit Preparation and Supporting Mock Audit
o Support the controlled and structured Hand-Over of the Site at its
last day.

Produktionsplan, Gefahrstoffmanagment, Softwaredokumentation, Train the Trainer, Installation / Montage / Wartung (allg.), Manufacturing Resources Planning, Good Manufacturing Practices, Arbeitsschutzmanagement / Arbeitssicherheitsmanagement, Archivierung, Compliance management, Dokumentenmanagement, Fachkraft für Arbeitssicherheit (FASi), Produktionsoptimierung, Prozessmanagement, Qualitätsdokumentation, Technische Dokumentation, Total-Quality-Management, Unternehmensberatung

6/2016 – 12/2016

- Project Coordinator:
o Assess the current status against previous FDA- and Notified
Body- Findings
o Identify urgently needed activities before the FDA-Audit is taking
place
o Plan and Support Remediations
- Project Support:
o Support the ongoing Updates of SOP´s / Engineering Documents
/ Risk Management Files
o Review and optimize the Traceability of Products
o Finish the open Complaint Handling activities

Compliance management, Risikomanagement, Projektleitung / Teamleitung, Projektmanagement - Audits, Corporate Behaviour, Unternehmensberatung, Dokumentenmanagement

1/2016 – 5/2016

- Project Support:
o Review and Update related Quality Documents
o Review and Support ongoing activities for NC/CAPA´s and
Customer Complaints
o Support needed Supplier Audit
o Perform internal “Worst Case”-Audit (Role as a “Worst-Case”-
Auditor)
o Trainings local Management in Audit Topics

Lieferantenmanagement (allg.), Regulatory Affairs, Auditor, Unternehmensberatung, Dokumentenmanagement, Führungstraining

3/2015 – 12/2015

- Project Support:
o Support the local Project Managers and Coordinate a structured
Remediation between 3 Sites
o Support the Change of the complete Product Portfolio (sterile and
non-sterile) to UDI (Unique device identification) Compliant Labels
▪ Affected products: Sterile Implants, Single-Use, Injectable
cements and artificial bone, antibiotic coatings, BMPs
o Update the internal SOP´s and WI´s to ensure a compliant
creation and inspection of UDI-conforming Barcodes and Human
readable Information on Labels
o Point of Contact for all external suppliers and internal worldwide
divisions regarding UDI
o Review ongoing and newly created NCR´s/CAPA´s and
Complaints against Labeling / Traceability Issues and implement
appropriate Corrections and Remediations

Auditor, Dokumentenmanagement, Projektmanagement - Risikomanagement, Prozessoptimierung, Risikomanagement, Verkehrsplanung, Unternehmensberatung, Verpackung und Kennzeichnung, Verpackungslogistik

1/2015 – 2/2015

- Project Support:
o Assess the current status against previous FDA- and Notified
Body- Findings
o Review closed activities before the FDA-Audit is taking place
o Support the last ongoing Updates of SOP´s / Engineering
Documents / Risk Management Files
o Support finishing the open Complaint Handling activities
o Preparation the Audit (incl. “Behavior-Training”)

Supplier Relationship Management (SRM), Regulatory Affairs, FMEA (Failure Mode and Effects Analysis), Compliance management, Qualitätsmanagement (allg.), Corporate Behaviour, Technische Dokumentation

8/2013 – 12/2014

Durchführung Legacy Review, CAPA, NCR, Abarbeitung TÜV-/FDA-Findings, Erstellung Hygienekonzept, Umzug einer gesamten Abteilung, Schulung Mitarbeiter, Sterility Assurance

Schulung / Training (IT), Change Management, Schulung / Coaching (allg.)

10/2008 – 7/2013

Durchführung mehrerer Projekte bei diversen Kunden im angegebenen Zeitraum in den Bereichen:
- Aufbau von Managementsystemen (ISO 9001, 13485, 14971, FDA, CMDCAS)
- Unterstützung bei der Zulassung von Medizinprodukten (Konformitätsbewertungsverfahren)
- Auditvorbereitung und -begleitung
- Aufbau CAPA-/Risk-Management
- Aufbau HSE/Arbeitsschutzmanagement
- Erstellung Hygienekonzepte
- Validierung / IQ / OQ / PQ
- Schulung von Mitarbeitern
- Kommunikation mit Behörden und Zertifizierern

Qualitätsmanagement / QS / QA (IT), Schulung / Training (IT), Technisches Qualitätsmanagement / QS / QA, Fehlermöglichkeits- und Einfluss-Analyse (FMEA / FMECA), Arbeitsschutzmanagement / Arbeitssicherheitsmanagement, Gesundheit und Sicherheit am Arbeitsplatz, Medizintechnik, Management (allg.), Risikomanagement, Qualitätsmanagement (allg.), DIN EN ISO 9001, Schulung / Coaching (allg.)