Experienced in/as QP/Head of QA/QC and R&D, ISO/GMP/FDA audits, Projectleader

freiberufler Experienced in/as QP/Head of QA/QC and R&D, ISO/GMP/FDA audits, Projectleader auf freelance.de
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14.10.2016

Kurzvorstellung

Experienced project leader from Development through to phase I and phase II projects for companies like Novartis and Solvias and from Phase III to commercialization for a contract manager.
My technical background used in R&D and QA is quite unique.

Ich biete

Forschung, Wissenschaft, Bildung
  • Forschung & Entwicklung (allg.)
Management, Unternehmen, Strategie
  • Projektleitung / Teamleitung

Projekt‐ & Berufserfahrung

QA Manager
Kundenname anonymisiert, Liestal
9/2016 – 10/2016 (2 Monate)
Life Sciences
Tätigkeitszeitraum

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

Eingesetzte Qualifikationen

Change Management, Management (allg.), Qualitätsmanagement (allg.), Auditor


ISO Project Leader
Kundenname anonymisiert, Zürich
8/2016 – 8/2016 (1 Monat)
Nano Technologie
Tätigkeitszeitraum

8/2016 – 8/2016

Tätigkeitsbeschreibung

Preliminary Project: implementation of ISO 13485
- GAP analysis

Project will start in 2017.

Eingesetzte Qualifikationen

Projektleitung / Teamleitung, Projektdurchführung, DIN EN ISO 50001, Auditor


QP, Head of QA and R&D
Kundenname anonymisiert, Möhlin
11/2012 – 7/2016 (3 Jahre, 9 Monate)
Lohnhersteller
Tätigkeitszeitraum

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.

Eingesetzte Qualifikationen

ERP Beratung (allg.), Hardware Entwicklung, Qualitätsmanagement / QS / QA (IT), Change Management, Management (allg.), Auditor, Forschung & Entwicklung (allg.), F&E Management


Director HT Experimentation
Kundenname anonymisiert, Augst
5/2010 – 10/2012 (2 Jahre, 6 Monate)
High-Tech- und Elektroindustrie
Tätigkeitszeitraum

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)

Eingesetzte Qualifikationen

Postsales, Forschung & Entwicklung (allg.), F&E Management


Head of QC
Kundenname anonymisiert, Möhlin
4/2009 – 4/2010 (1 Jahr, 1 Monat)
Lohnhersteller
Tätigkeitszeitraum

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)

Eingesetzte Qualifikationen

Qualitätsmanagement / QS / QA (IT), Schulung / Training (IT), Gute Herstellungspraxis (GMP), Projektleitung / Teamleitung, Personalwesen (allg.), Qualitätslenkung


Workflow Architect Life Science Europe/Asia
Kundenname anonymisiert, Basel
5/2008 – 3/2009 (11 Monate)
Life Sciences
Tätigkeitszeitraum

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

Eingesetzte Qualifikationen

IT-Beratung (allg.), Prozess- / Workflow, Architektur (allg.), Organisation (allg.), Physik


Head of Catalysis
Kundenname anonymisiert, Basel
1/2005 – 5/2008 (3 Jahre, 5 Monate)
Life Sciences
Tätigkeitszeitraum

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

Eingesetzte Qualifikationen

Gute Herstellungspraxis (GMP), Forschung & Entwicklung (allg.)


Project Leader and Laboratory Head
Kundenname anonymisiert, Kaiseraugst
9/1997 – 12/2004 (7 Jahre, 4 Monate)
Life Sciences
Tätigkeitszeitraum

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

Eingesetzte Qualifikationen

Qualitätsmanagement / QS / QA (IT), Rechnergestütztes Betriebsleitsystem (RBL), Gute Herstellungspraxis (GMP), Projektleitung / Teamleitung, Auditor, Pharmazie, Chemie


Ausbildung

PostDoc of the University of British Columbia, Vancouver, Canada
(PostDoc)
Jahr: 1997
Ort: Vancouver, Canada

Chemistry at the Federal Institute of TEchnology (ETH) Zürich
(Ph.D.)
Jahr: 1996
Ort: Zürich, Switzerland

Qualifikationen

20 year's experience in R&D, production and QA of Pharma products and leadership.
My technical background used in R&D and Production as well as in QA in a way is unique.

Über mich

We are looking for projects in following fields:
- 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

Persönliche Daten

Sprache
  • Deutsch (Muttersprache)
  • Englisch (Fließend)
  • Französisch (Grundkenntnisse)
Reisebereitschaft
auf Anfrage
Arbeitserlaubnis
  • Europäische Union
  • Schweiz
  • Vereinigte Staaten von Amerika
Profilaufrufe
880
Alter
52
Berufserfahrung
22 Jahre (seit 09/1997)
Projektleitung
20 Jahre

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