2018                             

Project Manager Electrical Engineering (EE) R&D Laboratories

Client                           

One of the leading global suppliers of innovative cleaning, disinfection and sterilization solutions for medical and life science, Headquarter, Switzerland

Responsibilities            

I was responsible for the final development and qualification of a new designed medical washer and disinfector. Qualification tests were conducted according IEC 61010-1 and IEC 61010-2-040. With motivation, training and technical expertise I had led my team. I reviewed and advised for completion of the electrical schemes, calibrations, exchange of components, creation of the list of critical components and more.

Achievement              

The certification has been done timely for EMEA, Asia, Canada and US regions. The TÜV Certification process has been prepared, supported and passed the TÜV exam successfully. I conducted the IEC 61010 qualification tests prior to the ICEE (IEC System for Conformity Testing and Certification of Electrical and Electronic Components) CB (Certification Body) scheme tests for the new developed medical washer and disinfector. The new product has been brought to the market timely.

 2017                             

Atomic Spectrometry Computer System Validation ICP-OES and Global SOP Manager

Client                           

Global Fine Chemicals Manufacturer, a large Fortune listed Company

Responsibilities            

I was in charge of the development of the process model and the implementation of a Global SOP (GOP) for Atomic Spectrometry and its specific changes. I developed and completed the SOP and trained my team for the implementation. Furthermore, the Validation Master Plan of the ?Inductive Coupled Plasma- Optical Emission Spectrometry? (ICP-OES) Systems has been developed and approved as well as the spectrometry data maps. Additionally, traceable and testable requirements for the Atomic Spectrometry Analytics have been defined.

Achievement                          

SOP and Validation documentation have been developed in time. International cross functional teams have been successfully set up and trained. An FDA Inspection has been prepared and passed successfully.

2016-2017

Interim-Manager

Client

One of the Top 5 Global Pharmaceuticals Companies

Responsibilities

As an Interim Manager for QA / FDA Consultant I was responsible for the processing of events and scientific writing, and for the review of investigation reports. I coached and developed the team in investigation and communicated with the regional and global experts.  

Achievement

The team successfully developed in investigation of events and scientific writing. Events have been reviewed and processed. Processes have been visualised and process improvements have been implemented. Corrective and preventive actions have been addressed. Correspondence with the ?Food and Drug Administration? (FDA) regarding the project progress.

2013-2015

Program & Project Manager

Client

One of the Top 5 Global Biotech/Pharmaceuticals Companies with its Sites in Austria

Responsibilities

Leading a multi-million ? system integration project: Chromatography Data System (including PLS connections) transition. I was organizational responsible for the team and the project deliverables.  One challenge of the project was to create the Validation Master Plan and realize the tasks within limited time frame. The other challenge of the project was to coordinate with more than 30 team members from different sites and supervise their work, including large offshore and third party contractors. The project was successfully rolled out across all Austrian sites with more than 4000 employees.   

Achievement

The project was completed successfully as scheduled. Computer software and hardware have been fully implemented, qualified and validated in time. Analytical instruments have been upgraded, connected and qualified. New and modern processes have been developed and established.

2012

FDA Compliance Manager

Client

One of the Top 5 Global Biotech/Pharmaceuticals Companies with its Site in Austria

Responsibilities

Analysis of the pharmaceutical sterile production processes and deviation management including identification of gaps and root causes. Documentation within the TrackWise IT- system; Improvements for the operational excellence were developed and implemented resulting in a remarkable future cost reduction.

Development of cGMP procedures; ?corrective and preventive actions? (CAPA) were scheduled, implemented and documented. Batch release references were given.

Achievement

Business processes were analyzed and deviations were examined. According its risk assessments CAPA?s were implemented. Batches have been recommended for release according its risk assessment.

2011

Business Process Manager

Client

Nycomed / Takeda in Germany

Responsibilities

Business Process Analysis (BPA) for a pharmaceutical sterile production outsourcing project and BPA visualization, including all IT-systems and IT-related interfaces of the whole company. A strategy and method for the successful transformation was developed for an SAP upgrade project.

Achievement

Core business processes and interfaces were identified, analyzed and visualized. The pharmaceuticals production and the business processes of the whole site were visualized for the major change. A detailed process landscape was built. Global standards have been developed and documented waiting for the implementation decision.

2010-2011

Quality and Compliance Manager

Client

Boehringer-Ingelheim Pharma GmbH & Co. KG in Germany

Responsibilities

As a Quality and Compliance Manager within the Program Management Office & Governance department I audited global projects and program applications according Standard Operating Procedures (SOP).

Together with my team I optimized the Global Master SAP Templates to achieve time savings in operational use and cost reductions.

Achievement

Project and program deliverables were analyzed; audit reports were established according the project schedule. Recommendations were given according the risk based approach.

2009-2010

Validation Project Manger

Client

Ayanda GmbH, Falkenhagen,  Germany

Responsibilities

As Validation Project Manager for the global set up of the ERP and MES Navision system I was responsible for all validation activities according GAMP 5.  I structured User Requirements, analyzed Functional Specifications, and conducted Risk Analysis according ICH Q9. I created Test plans and Test reports and developed, implemented and trained the new procedures within the manufacturing department and high risk areas such as MES, In-Process-Control Analytics and Warehouse Management.

Achievement

Functional Specifications were set up together with the manufacturer of the application and a new structure for the integration of new sites was implemented in time. I found one way to motivate BPO and Key User to fulfil all the necessary work packages. Milestones were set and met in time.

2008

Quality Manager

Client

Stryker Leibinger GmbH & Co. KG, Freiburg im Breisgau, Germany

Responsibilities

I created the SOP ?phasing of manufacturing processes? and developed an evaluation grid for the use with ?process failure mode and effect analysis" FMEA.      I implemented the SOP in the Stryker Global Quality System.

Analysis and logic design of an inventory identification system were conducted.

The new system has been implemented successfully.

A medical device has been reengineered to achieve future cost reductions.

Achievement

The SOP secured the right phasing of manufacturing processes and was part of the quality system. FMEA procedures minimized the likelihood of serious errors.

The new inventory management system was well structured and updated.

The reengineered medical device saved human lives and gained profits, as it was easier to use and cheaper in production.

2008

Program & Project Manager

Client

Consult S.A., Luxembourg

Responsibilities

As program and project manager I was responsible for standardization and transition of an IT environment into a ?shared service approach?.

I divided the project into measurable units and motivated manager and staffs to promote the project. My work package plan for the 30 colleagues helped fulfil all necessary tasks in time.

Achievement

The ?shared service approach? was divided in units and implemented step by step. These units assured measurable project progress. Each unit has had a unit specific roll back procedure in place.

The work packages were conducted in time.  All procedures were documented and approved according Good Documentation Practise GDP rules.

2007-2008

Quality Manager

Client

Sirona Dental Systems GmbH, Bensheim, Germany

Responsibilities

As Quality Manager I was responsible for planning and conducting of all system tests of a new developed treatment unit, supported by an internal 5-person team and an external 14-person team. I developed test cases and documentation according EN 60601. I consulted the integration team and gave training about the test contents e.g. test depth, level of automation.

Achievement

Improvements of circuit diagrams and PCB were addressed and successfully implemented. The necessary tests were done and supervised; the requirements of EN-60601 were fulfilled and documented in time and in line with the budget.

2006-2007

Project Quality Manager

Client

Novartis Pharma AG, Basel, Switzerland

Responsibilities

As Project Quality Manager in the department of Development IT Quality Management & Processes, I was responsible for analysing and steering multiple projects at several global locations and identifying areas of improvement.

The centralized steering of the world wide migration of approximately 250 databases of a former merger according Novartis Quality System, methodology and procedures was one of my tasks.

Achievement

Global distributed clinical databases were successfully migrated according the Data Migration Plan. I developed the plan together with the vendors according Quality Manual, SOP`s and Novartis methodology.

New Sites and application extensions were planned and supervised. Therefore I classified all IT applications including TrackWise and other applications. New project mandates have been created depending on my classification. Material and human resources were planed and time frames and milestones were set.

New logistics and qualification strategies were implemented to reflect characteristic of new sites. Areas of improvement were identified and adressed to assure the best business performance.

2002-2005

Project Quality Manager

Client

Pfizer Global Research and Development (PGRD) sites: Groton (Headquarter US, Connecticut), Sandwich (European Headquarter UK, Kent), Fresnes (F, Paris), Kalamazoo (US, Michigan), Freiburg (im Breisgau, Germany)

Responsibilities

As CDS Project Quality Manager I was responsible for development, validation and administration within global IT environment. Local installations and configurations of Global Chromatography-Data-System Millennium 32 V 4.0 were customized for Pfizer Global Research and Development locations. I wrote Validation Tests, SOP?s and verified reports; I tested against the 21 CFR part 11 specifications and assured compliance to Pfizer?s internal methodology, Gamp 4 / ISPE etc.

I was responsible for advising global technical teams and reporting their progress to GM. I recruited and led project team members. I did migrations of legacy data and was a transition team key person for all Freiburg Chromatography Data Systems.

I supported Oracle- Citrix and Fileservers. I did qualification tests and documented them. I created contingency plans and qualified Acquisition Server, Oracle Server, Terminal Server and File Server.

I supported IT-systems retirement after R&D site closure decisions technically and organizationally. I was responsible for selected validated data and long term storage of chromatography data for the Business Units in Europe and US.

Achievement

CDS Millennium was enrolled on time. I tracked progress, time lines, costs and resources.  The validated status was generated and kept. Old Chromatography Data Systems were retired. Data was saved and archived. Validated systems were maintained to keep their status. This ensured the validity of systems and data throughout the entire system life cycle.