Bisherige Tätigkeiten:

Boston Scientific International BV (Kerkrade, Netherlands)

June 2015 till now

Senior QA Manager

• In Charge for:

- Ensuring the Quality System to substantially compliant to GMP/QSR acc. FDA, ISO and regulatory bodies

- Developing and generating quality metrics reporting tools as well as process improvements

- Responsibility for trending/analysis of any Quality data

- Sharing periodic information across the Regional Quality Team

- Responsibility for interacting with internal BSC sites and external customers on Quality related issues

- Providing vision and leadership for strategic projects with significant impact within the site and Corporation;

- Working collaboratively across functions, regions and business units to implement project strategies

- Leading a group or team of employees in the achievement of organizational goals.

- Guiding, coaching direct, and developing direct reports

- Fostering a diverse workplace that enables all participants to contribute to their full potential

- Directing and controlling the activities and budget of the functional area,

- Monitoring and ensuring compliance with company policies and procedures

Senior Quality Systems & Compliance Specialist

• In Charge for:

- Consultant for DEKRA and FDA Audit Preparation

- Internal Lead Auditor on site (using MDSAP approach)

- Lead Auditor for Supplier Audits

- Global Subject Matter Expert for Management Review Process

- Local & European Management Review

- CAPA Review Board

- CAPA Mentor Role

- Approver role for all SOPs and WIs

• Projects

- Successful GAP Analyses of the existing local and global QM System regarding ISO 13485 and CFR Part 820

compliance

- Review of CAPAs and Nonconforming Events regarding Compliance Risks

- Review of Management Review Processes regarding Data Integrity and Compliance

- Define the cascading down Process from QMR into all functional areas within the organisation

- GAP Analyses of existing FMEAs and manage the project to close those identified gaps

Maxon Motor AG, BU Medical (Sachseln, Switzerland)

January 2013 till June 2015

Quality Engineer (Deputy Head of QA Department)

• 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 of new products (DHF responsibility)

- Complaint handling process

- Supplier Management

• Projects

- Successful GAP Analyses of the existing global QM System regarding ISO 13485 and CFR Part 820 compliance

- Development and successful implementation of a slim risk based approach for global Qualification and

  Validation Process CSV and MSA (Measurement System Analyses) in accordance of ISO 13485 and CFR Part

  820 requirements

- Several Qualification, Validation and CAPA Projects

- Several R&D projects (QA representative)

Abbott Vascular Ltd (Beringen, Switzerland)

October 2010 till December 2012

Senior Compliance Analyst

• In Charge for:

- Leading of Management Review and the Corrective Action Board on site

- Preparation and conduction of global Management Review

- Responsibility for global stop shipment and recall process as well as data preparation for stop shipment and recall

Decisions

- Responsibility for the training system and Audit processes on site

- Leadng of Audit preparation for AQR, TUV, ANVISTA and FDA Audits

- Consulting and Reporting of Senior Management regarding all internal and external Compliance Questions

• Projects

- Development of Processes and Tools for Quality Data Analyses

- Defining Quality Goals

Compliance Specialist

• In Charge for:

- Subject Matter Expert for the CAPA and Complaint handling processes

- Abbott CAPA Certified Trainer (for Initiator, Investigator, Resolution Planner and Approver function)

- CAPA Mentor on site

- Lead of Nonconforming Product Meeting

- Facilitator for Process FMEA

• Projects

- Successful implementation of the Divisional Nonconforming Material and reporting processes as well as for the

  CAPA System inclusive development of CAPA and Scrap trending processes for Nonconforming Risk Data

- DHF Assessment acc. to 21 CFR part 820.30 requirements

Quality Engineer

• 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 Planning and Effectiveness Phases)

- QA R&D Support (DHF Creation)

Josteit & Krüger Consulting GmbH (Moers, Germany)

January 2010 till September 2010

Head of QM

• In Charge for:

- Organization of the QM Department

- Preparation and alignment of the internal QM System

- CSV

- External Trainings

• Projects

- Successful preparation of specifications for the software development in compliance with GAMP 5 within global

   IT-Projects

- Effective Elaboration of Validation strategies in accordance of a risk based approach in compliance of ICH

  Guidelines

- Consultant for cGMP Compliance within PAT and QbD Projects

Christ Pharma & Life Science GmbH (Vaihingen, Germany)
November 2007 till December 2009

Validation Manager

• In Charge for:

- Qualification and Validation of Watertreatmentsystems (Aqua Purificata, Water for Injection, Pure Steam) and

   Decontamination Systems

- Global Trainer (internal and external) for Qualification and Validation of Water treatment Systems

- Writing Work Instructions and SOPs

- Internal and External Trainer

• Projects

- Several global Qualification and Validation Projects with high complexity

- Successful implementation of Standard processes (Master Documentation) in alignment of GAMP 5 (Risk based

   Approach)

GlaxoSmithKline Consumer Healthcare GmbH & Co. KG (Herrenberg, Germany)

March 2007 till October 2007

• Thesis

- Subject: "Technical, functional, qualitative and economic aspects of water treatment plants for the production of purified water in a pharmaceutical company and its proper qualification under the current regulations."

Roche Diagnostics GmbH (Mannheim, Germany)

August 2005 till February 2006

• Second internship

- CSV (Excel Sheets for analytic calculations)

- OPEX (Development and successful implementation of databases for the Identification and Evaluation of

  KPI's)

- Validation of analytic methods for product release regarding GxP Compliance (analytic measuring method

   validation)

GlaxoSmithKline Consumer Healthcare GmbH & Co. KG (Herrenberg, Germany)

March till August 2004

• First internship

- Process and Cleaning Validation of complete Bulk and Confection Lines for Liquida inclusive the preparation of

  the QM documentation (SOP, Work instructions)

- Preparation of KPIs (Key Performance Indicators) for OPEX Implementation