freiberufler Freelancer Medical Device / Pharmaceutical Industry auf freelance.de

Freelancer Medical Device / Pharmaceutical Industry

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  • 76571 Gaggenau
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  • de  |  en  |  fr
  • 18.10.2018

Kurzvorstellung

I'm a freelancer working for the medical device and the pharmaceutical industry within the field of Quality Management / Quality Assurance.

Ich biete

  • FMEA (Failure Mode and Effects Analysis)
  • Qualitätsmanagement / QS / QA (IT)

Projekt‐ & Berufserfahrung

Quality Engineer (Deputy Head of QA Department)
Kundenname anonymisiert, Sachseln
1/2013 – 6/2015 (2 Jahre, 6 Monate)
Medical Device Industry
Tätigkeitszeitraum

1/2013 – 6/2015

Tätigkeitsbeschreibung

In Charge for:
- Lead of external Audits and Audit-preparation
- Internal Auditor on site- Global Subject Matter Expert for Validation and Qualification
- Global Trainer for Qualification and Validation processes
- Responsible for the release of specifications for incoming inspections as well as the FAI (First Article
Inspection)
- Risk Management (FMEA Moderator for Process and Design FMEAs)
- QA representative within development projects of new products
- Complaint handling process
Projects:
- Successful GAP Analyses of the existing global QM System regarding ISO 13485 andCFR Part 820
compliance
- Development and successful implementation of a slim risk based approach for globalQualification and
Validation Process CSV and MSA (Measurement System Analyses) in accordance of ISO13485 and
CFR Part 820 requirements
- Several Qualification, Validation and CAPA Projects

Eingesetzte Qualifikationen

Management (allg.), Risikomanagement, Fehlermöglichkeits- und -einflussanalyse (FMEA), Auditor

Senior Compliance Analyst
Kundenname anonymisiert, Beringen
3/2012 – 12/2012 (10 Monate)
Medical Device Industry
Tätigkeitszeitraum

3/2012 – 12/2012

Tätigkeitsbeschreibung

In Charge for:
- Lead of Management Review and the Corrective Action Board on site
- Preparation and conduction of global Management Review
- Responsible for global stop shipment and recall process as well as data preparation forstop shipment
and recall Decisions
- Responsible for the training system and Audit processes on site
- Lead of Auditpreparation for AQR, TUV, ANVISTA and FDA Audits
- Consulting and Reporting of Senior Management regarding all internal and externalCompliance
Questions
Projects:
- Development of Processes and Tools for Quality Data Analyses- Defining Quality Goals

Eingesetzte Qualifikationen

Reporting, Management (allg.), Auditor

Compliance Specialist
Kundenname anonymisiert, Beringen
2/2011 – 2/2012 (1 Jahr, 1 Monat)
Medical Device Industry
Tätigkeitszeitraum

2/2011 – 2/2012

Tätigkeitsbeschreibung

In Charge for:
- Subject Matter Expert for the CAPA and Complaint handling processes
- Abbott CAPA Certified Trainer (for Initiator, Investigator, Resolution Planner andApprover
function)
- CAPA Mentor on site
- Lead of Nonconforming Product Meeting
- Writing Process FMEAs
Projects:
- Successful implementation of the Divisional Nonconforming Material processes as wellas the global
reporting process for the CAPA System inclusive development of CAPA and Scrap
trendingprocesses to calculate Nonconforming Risk Data

Eingesetzte Qualifikationen

Reporting, FMEA (Failure Mode and Effects Analysis), Schulung / Training (IT), Risikomanagement

Quality Engineer
Kundenname anonymisiert, Beringen
10/2010 – 1/2011 (4 Monate)
Medical Device Industry
Tätigkeitszeitraum

10/2010 – 1/2011

Tätigkeitsbeschreibung

In Charge for:
- Qualification and Validation (Process- , Computer- and Cleaning Validation)
- Product Release- Investigation and documentation of Complaints- Writing Work Instructions and
SOPs
Projects:
- Successful reorganization of the Corrective Action Board
- Owner of various global CAPA projects (Initiation, Investigation, Resolution Planningand
Effectiveness Phases)
- Lead of Technical Review Meeting

Eingesetzte Qualifikationen

BOARD, Risikomanagement

Head of QM
Kundenname anonymisiert, Moers
1/2010 – 9/2010 (9 Monate)
Pharmaceutical Industry
Tätigkeitszeitraum

1/2010 – 9/2010

Tätigkeitsbeschreibung

In Charge for:
- Organization of the QM Department- Preparation and alignment of the internal QM System
Projects:
- Successful preparation of specifications for the software development in compliancewith GAMP 5
within global IT-Projects
- Effective Elaboration of Validation strategies in accordance of a risk based approach incompliance of
ICH Guidelines- Consultant for cGMP Compliance within PAT and QbD Projects

Eingesetzte Qualifikationen

Qualitätsmanagement / QS / QA (IT), FMEA (Failure Mode and Effects Analysis), Softwareentwicklung (allg.), IT-Beratung (allg.), Risikomanagement

Validation Manager
Kundenname anonymisiert, Vaihingen
11/2007 – 12/2009 (2 Jahre, 2 Monate)
Pharmaceutical Industry
Tätigkeitszeitraum

11/2007 – 12/2009

Tätigkeitsbeschreibung

In Charge for:
- Qualification and Validation of Watertreatmentsystems (Aqua Purificata, Water forInjection,
Pure Steam) and Decontamination Systems- Global Trainer (internal and external) for
Qualification and Validation of Watertreatment Systems
- Writing Work Instructions and SOPs
Projects:
- Several global Qualification and Validation Projects with high complexity- Successful implementation
of Standard processes (Master Documentation) inalignment of GAMP 5 (Risk based Approach)

Eingesetzte Qualifikationen

Schulung / Training (IT), Wasseraufbereitung / Abwasserreinigung, Management (allg.), Public Relations

Ausbildung

Pharmazeutische Technologie; Fachrichtung QM
(Dipl.-Ing. Pharmatechnik (FH))
Jahr: 
Ort: Albstadt-Sigmaringen
Assistent im Gesundheits- und Sozialwesen
(Ausbildung)
Jahr: 
Ort: Buehl

Qualifikationen

Proficient expertise in Quality Regulations and Guidelines as ISO 13485, ISO 9001, ISO 19011, ISO 14971, MPG, EG GMP Guideline, AMG, AMWHV, 21CFR, GAMP5, IEC 62304

Proficient with: Quality Assurance; Quality Management Requirements; Quality control; Product Development; Project Management; Process optimization; FMEA; Risk Management; Change control; Auditing; Qualification; Validation; CAPA System; Medical Device Regulations; Clean Room Requirements; CSV; Packaging; Trainer; Document Managing; GMP; Sterilisation; First Article Inspections; Statistical Quality Control; Six Sigma

Software Skills
MS Office Tools: MS Outlook, MS Word, MS Excel, MS PowerPoint, MS Access, MS Visio, MS Project
ERP Systems: ARGO and IFS
Other: AutoCAD (CAD), Comos PT (Process Planning Tool), CatsWeb (Exception and CAPA Database), CAQ (Computer Aided Quality), Apis IQ-FMEA, Minitab (Statistic software)

Über mich

I have a solid academic study in pharmaceutical technology with specialization in Quality Management.
My expertise I collected the last 8 years within different functions in the Quality Management of different global pharmaceutical and medical device companies.
From January 2013 till June 2015 I work as Quality Engineer and deputy Head of QA at Maxon Motor AG, Business Unit Medical in Sachseln, Switzerland. I’m responsible for all Qualification and Validation Processes, leading external Audits and execute internal Audits. From October 2010 till December 2013 I worked in different functions as Quality engineer, compliance specialist and senior compliance analyst at Abbott Vascular in Beringen, Switzerland. I was responsibel for the Qualification and Validation Process, the nonconforming material handling process and the CAPA System. I was subject matter expert (SME) and trainer for the the CAPA Sytem and responsible for stop shipments and recall activities in compliance with internal and external regulations.From January till September 2010 I worked as Head of QM at Josteit & Krüger Consulting GmbH in Moers, Germany. I was responsible for the GAMP 5 compliance within global IT-Projects and for the effective Elaboration of Validation strategies in accordance of a risk based approach in compliance of ICH Guidelines and consultant for cGMP Compliance within PAT and QbD Projects.From November 2007 till December 2009 I worked as Validation Manager at Christ Pharma & Life Science GmbH in Vaihingen, Germany. I was responsible for all Qualification and Validation activities for water treatment systems for global pharmaceutical, medical device, cosmetic and food companies. I poise as expert for problem solving and have a solution oriented pracctice.

Persönliche Daten

Sprache
  • Deutsch (Muttersprache)
  • Englisch (Fließend)
  • Französisch (Gut)
Reisebereitschaft
Weltweit
Arbeitserlaubnis
  • Europäische Union
  • Schweiz
Home-Office
unbedingt
Profilaufrufe
2208
Alter
43
Berufserfahrung
17 Jahre und 9 Monate (seit 03/2004)
Projektleitung
2 Jahre

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