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Christoph Dr. Wambach
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Senior Expert, Interim Head/Director Operations/Quality, GxP Auditor
, Life-Sciences, Pharma, BioTech, MedTech; work experience UNIDO, GIZ
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Bonn,
Germany
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International experienced Senior Expert, Consultant and qualified GxP/ISO Auditor. Strong leader with experience in (Bio)Pharma, Bio & MedTech. Set-up and improved (global)QMS, lead int. dev. projects and experienced in Europe, Asia & Arabia. I'm looking for international Interim or contract assignments with leading responsibility in Operations/Quality. Currently available for worldwide challenges |
 Contact Christoph Dr. Wambach
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Area of Expertise: |
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Administration, Management, Finance/Accounting, Procurement
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Director, CEO, COP, President
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Health, Doctors, Nurses, HIV/AIDS
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Monitoring, Evaluation, Policy, Research, Analysis
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Professional Experience: |
- 1999 till 2013: foundation, leading and developing an international active service laboratory for pharma, biotech, food, feed and seed testing. As CEO responsible for general management, international marketing and consultancy, Quality-Manager & Auditor, international Trainer and Lecturer in Quality related topics;
- Between 2008 and 2010: Consultant and Auditor in several short term assignments at five governmental food testing laboratories in Bangladesh on behalf of UNIDO. The project was cofinanced by the EU and was focussed on improvement of testing capacities and regarded QM systems. Included was the design and planning of a new laboratory for heavy metal testing at BAEC, Dhaka.
- Between 2011 - 2014: Consultant and Auditor in several short term assignments in Saudi Arabia for QMS improvement and centralization of the Saudi Arabian Food & Drug Authority (SFDA). Involvement of different laboratories all over Saudi Arabia, planning and conducting several workshops/trainings on Quality Management, laboratory safety, molecular- and microbiological test methods. Centralization of the existing QM-systems, setting up a new headquarters in Riad and preparation of SFDA laboratories for ISO17025 accreditation.
- 01-2014 - 03-2015: recapitalization and reorganizing of a bankrupt food testing laboratory in Germany. Worked as consulter, QM manager and 6 month with authorized signatory
- 04 till 07-2015: auditor and trainer in international short-term projects
- 08-2015 till 03-2016: Gettinge/Maquet Germany: Senior expert consultant in a laboratory project in MedTech under ISO13485; qualification and validation topics; improvement of class III MedTech product sampling for bacterial endotoxin testing
- 01-2016 till 10-2017: Boehringer Ingelheim BioPharma plant in Biberach, Germany: Project leader with budget and staff responsibility; international cross-site project for the improvement of bacterial endotoxin testing. Setting up global SOPs and guidelines for conducting hold-time studies. Planned, lead and evaluated these studies, management of out-sourced activities and improvement of sampling procedures. Acted as Subject Matter Expert in FDA inspections and customer audits.
- 11-2017 till 01-2019: Interim Head of Quality at Woerwag Pharma, Germany with Budget and staff responsibility.
*Developed the QMS, its documentation system and the department itself restructuring the teams and onboarding new staff;
*Regular reporting to CMO and on directors level.
*Planned and set quality related KPIs;
*Created, planned and monitored quality related improvement projects (e.g. new CAPA & deviation MM, transport validation);
*Lead international recalls and change processes;
*Acted as contact partner to suppliers (CMOs, API manuf., laboratories, logistics) and authorities;
*Controlled, evaluated and trended deviations, complaints, results of stability studies, changes and CAPAs;
*Conducted several international GxP audits as lead at CMOs, API
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Education: |
- Doctorate in Chemistry, University of Bonn, Germany, very good
- Consultancy and marketing of pharmaceutical products, Parke Davis GmbH/Gödecke AG, Freiburg, Germany
- QM auditor ISO 9001, educated at TUV Rheinland, Germany
- QM auditor for safety, health and environment in industry, educated at TUV Rheinland, Germany
- internal Auditor for IFS, BRC and ISO 220000, educated at Bureau Veritas, Wuppertal, Germany
- international acquisition, 3 days workshop, London, March 2015
- cGMP compliance manager (2017, Concept Heidelberg)
- FDA and cGMP authority inspections Expert (2017, Concept Heidelberg)
- GMP, GLP & GDP auditor (2018, Wörwag Pharma)
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Available for: |
- Consulting assignments
- Job opportunities
- Internships / Fellowships
- Being headhunted – make me an
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