Bernd Janson Prozessmanagement
Aktuell
[News]
Über mich
[Profile]
Wissen
[Knowledge]
Dokumente
[Documents]
Leistungen
und Preise
Kontakt
[Contact]
    en
EXCLUSIVE FOR RECRUITERS
This is a special Websites for Recruiters: 
You can find information about Availability, Scope of interest, actual CV and Link to Pricelist.

 

AVAILABILITY
New contract at TAKEDA, Singen for 6 months, start was January 2018.

 

SCOPE FOR FREELANCE PROJECTS
Freelance Projects:
- Remediation Projects / Backlog
- Technical Writer (SOPs, Guidelines, IFUs)
- CAPA, NCR, Complaint Handling
- Process Control, Validation
- Regualtory Affairs, Riskmanagement ISO14971
- Quality Systems ISO 9001:2015 / ISO 13485:2016
- Transfer MDD to MDR (incl. UDI Labeling)

- 6-8 month, freelance project

Region D-A-CH
- Germany (Deutschland)
  Munich Area, Hamburg Area, Frankfurt Area

- Austria (Österreich)
  Salzburg / Wien / Klagenfurt Area

- Switzerland (Schweiz) 
  Zürich / Luzern / Bern / Solothurn / Basel Area

Region Europe
- Netherlands (Amsterdam Area)
- Denmark (Kopenhavn Area) 
- Ireland (Dublin / Cork Area)
- Malta (english only)

Region North America
- United States (Boston Area)
- Canada (Vancouver, Toronto Area) 

Region Australia
- Sydney Area
- Perth Area
(8-12 month project only because of the 
very long distance for travelling)

 

SKILLS AND EXPERTISE
- 20 Years of Experience in Quality Management (since 1997)

Quality Skills
- Corrective and Preventive Action (CAPA)
- Non-conforming Requests (NCR)
- Change Management (DCR/DCO; ECR/ECO)
- Investigation & Root Cause Analysis (5Why, 5M-Method, Fishbone, Is/IsNot)
- Complaint Handling
- GxP, GMP, GDP

Regulatory Skills
- ISO 9001:2015 
- ISO 13485:2016
- FDA CFR 820
- Medical Devices Directive MDD 93/42/EWG (MDR in planning)
- In-Vitro Diagnotics IVD 98/79/EC (IVDR in planning)
- Riskmanagement ISO 14971:2012
- Regulatory Affairs / Technical File (STED)

Computer Skills
- MS Office (actual in Version 2000, 2003, 2007, 2010)
- Microsoft Document Management System (DMS)
- Oracel AGILE Document System
- SAP ERP-System

Language Skills
- German (native)
- English (fluent) 
 

CV (Lebenslauf)
Profile

- Actual Profile in English (WORD File)

  openCV
 
 Please visit also my LinkedIn and XING Profile. (Link see below)

PRICELIST
Prices

- Actual Pricelist (PDF File)

 
 

Für weitere Informationen rufen Sie mich an / For further informationen please give me a call:

++49 (0)176 - 270 30 741

 
Öffentliche Profile | Public Profiles
 
(c) 2010-2018 Bernd Janson. Alle Rechte vorbehalten