Experienced in/as QP/Head of QA/QC and R&D, ISO/GMP/FDA audits, Projectleader
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- 14.10.2016
Kurzvorstellung
My technical background used in R&D and QA is quite unique.
Qualifikationen
Projekt‐ & Berufserfahrung
9/2016 – 10/2016
Tätigkeitsbeschreibung
- Processing and tracking of deviation and CAPA’s (deviation management)
- Writing of validation protocols and reports
- Release of MBR (Master Batch Records) on the basis of a Q-checklist
- Batch record review including QC data review
- Release of intermediates (batch record review) incl. QC data review
- Release of raw materials based on the existing QC data
- Processing and tracking of changes
- Review and adaption of SOP’s (Standard Operation Procedures)
- Internal audits
Change Management, Management (allg.), Qualitätsmanagement (allg.), Auditor
8/2016 – 8/2016
Tätigkeitsbeschreibung
Preliminary Project: implementation of ISO 13485
- GAP analysis
Project will start in 2017.
Projektleitung / Teamleitung, Projektdurchführung, DIN EN ISO 50001, Auditor
11/2012 – 7/2016
Tätigkeitsbeschreibung
Responsible for the 1st successful FDA Qualification of the company with no is-sues (no 483)
Responsible for all quality aspects of the company (release of goods, deviation CAPA management, BRR, complaint management, change management, audit management..)Responsible for all technical aspects of the projects of the company; from site transfer to full development from Phase II to Commercial
Responsible for all validation work within the company including also the validation of a new ERP system.
Enterprise Resource Planning, Hardware-Design, Qualitätsmanagement / QS / QA (IT), Change Management, Management (allg.), Auditor, Forschung & Entwicklung, F&E Management
5/2010 – 10/2012
Tätigkeitsbeschreibung
Responsible for the technical Pre- and Post Sales Team in the automation of sample preparation, synthesis and formulation and explaining the technical details to the customer
Coordination of all technical projects incl. planning resources (personal and technical equipment), planning budgets and coordinating with customer test, demo, installation and services
Strong interaction with R&D to define the new needed technical tools.
Organization of Laboratory work for customer (demo and test)
Postsales, Forschung & Entwicklung, F&E Management
4/2009 – 4/2010
Tätigkeitsbeschreibung
Build up a GMP compliant analytic lab incl. GMP test protocols/methods, SOP, Calibration, Qualification, Validation Masterplan of all equipment’s and methods used - successfully audited by Swiss Medic and a variety of customers
Coordination of all analytic projects (internal and with external collaborators)
Analytical Project leading of site transfer projects
Analytical cost calculation/control for all GMP products in-house
Responsible for the quality control personal (incl. training)
Qualitätsmanagement / QS / QA (IT), Schulung / Training (IT), Good Manufacturing Practices, Projektleitung / Teamleitung, Personalwesen (allg.), Qualitätslenkung
5/2008 – 3/2009
Tätigkeitsbeschreibung
Domain expert in all life science application (bio-formulation, excipient study, force degradation, crystallization, polymorphism, synthesis etc.) by providing technical expertise applied to the overall application, workstations and analytical/physical property characterization components
Consultant for the customer’s internal champion(s) to help assemble a comprehensive strategy for implementation of high-throughput techniques throughout the customer organization.
Responsible for creating and presenting analysis of solutions to customers as part of the consultative sale/value analysis.
Present papers and/or give presentation at conferences and trade shows
It-Beratung, Workflows, Architektur (allg.), Organisation (allg.), Physik
1/2005 – 5/2008
Tätigkeitsbeschreibung
Coordination of all catalysis project within the group (approx. 50 projects per year).
Implementation of new research project eg: HTS screening module
Coordination of all GMP projects (clinical I studies) (1-2 project per year).
Responsible for TOX and GMP production for clinical phase (incl. production in house (TOX, GMP starting material) and production with 3rd parties (GMP)
Writing all SOP documentation for the set-up of a GMP Kilo lab
Good Manufacturing Practices, Forschung & Entwicklung
9/1997 – 12/2004
Tätigkeitsbeschreibung
Developed and implemented into production catalytic routes for agrochemicals, pharmaceuticals and fine chemicals in the field of CC-coupling reactions as well as heterogeneous hydrogenation.
QA responsible for the synthesis group in terms of GMP projects with customer
Establishing of QM system in the synthesis and catalysis group
Internal auditor for QM system
Qualitätsmanagement / QS / QA (IT), Rechnergestütztes Betriebsleitsystem (RBL), Good Manufacturing Practices, Projektleitung / Teamleitung, Auditor, Pharmazie, Chemie
Ausbildung
Vancouver, Canada
Zürich, Switzerland
Über mich
- Responsible for the consulting of customers in the following topics
- Implementation of the GMP and cGMP guideline
- Implementation of the latest ISO guideline (ISO13485 and ISO9001)
- Execution of validation and qualification (incl. QbD and Risk analysis)
- Validation of computerized systems
- Execution of supplier audits
- To put in place GMP/ISO systems
- To help out during staff shortage in the quality departments
Weitere Kenntnisse
My technical background used in R&D and Production as well as in QA in a way is unique.
Persönliche Daten
- Deutsch (Muttersprache)
- Englisch (Fließend)
- Französisch (Grundkenntnisse)
- Europäische Union
- Schweiz
- Vereinigte Staaten von Amerika
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