
Dipl.-Ing. Martina Schindek
Fähigkeiten und Kenntnisse
Werdegang
Berufserfahrung von Martina Schindek
- Bis heute 2 Jahre und 11 Monate, seit Okt. 2022
Senior Quality Assurance Manager
Viatris Pharma GmbH, Mylan Pharmaceuticals (a Viatris company)
• Designee of FvP/QP and responsible for product release for sale on market and return management • Responsible for trainig management for the whole affiliate (interims) • QA key person for Customer Service/Sales and Documentation Management • Responsible for optimization and improvement of QA processes
- 9 Monate, Juli 2021 - März 2022
E2E Process Expert
Fa. Hoffmann-La Roche AG
Implementing Phase of a Reorganisation • Responsible to ensure cGMP compliant aseptic compounding, sterile filling & visual control of liquid drug products for further human use in clinical trials • Operation Lead of Visual Control (5-7 employees) • Responsible for cGMP-documentation, batch record review (BRR) and approval, handle and assess deviations & change controls in close cooperation with various operation interfaces (Fixed-term contract through Global Personal Partner, Zurich, Switzerland)
- 5 Monate, Aug. 2020 - Dez. 2020
Senior Quality Assurance Expert
Lonza AG
QA Aseptic Manufacturing, clinicals for human use: • Batch record review (BRR) and final QA Release of drug substances and drug products for further human use in clinical trials • QA Oversight (Fixed-term contract, substitute of maternity leave through Entourage, Basel, Switzerland)
- 2019 - 2020
Senior Specialist Compliance / GMP / Quality
Pharmaplan (TTP Group)
80 % working time • Different project assignments in Quality Assurance and Qualification Projects at customer site • Quality / GMP Consultant and Teamlead for Quality activities • Consultant for GMP reviews of Conceptual and Basic Design documentation
- 2019 - 2020
Senior Consultant Qualifizierung
Pharmaplan (TTP Group) Projektassignment bei CSL Behring, Bern
Project at CSL Behring, Bern: Qualification (IQ/OQ, PQ), new biotech facility, aseptic manufacture of Immunoglobulin G (TIC 250 Mio CHF): • QA Project Leader managing the PQ of different clean media with all impacted operational and Quality leaders • Deputy of the Q Teamlead responsible for punctual conduction, monitoring and reporting of relevant Q activities successfully achieving project timelines • Support and review for customer approval of Q documentation including deviations and changes
- 2019 - 2019
Head of Quality Management
Rohner AG
• Management Lead of departements Quality Assurance, Quality Control & Security-Health-Environment • Responsible to ensure the maintenance, actualizing and improvement of cGMP compliance • Approval of all Quality relevant documents and processes e.g. qualification / validation, change & deviation management, CAPAS, SOPs, quality risk assessments etc. • Contact person and responsible for internal & external audits • Final approval of products for sale on market Company declared insolvency 06/19
- 2018 - 2019
Sabbatical, Training
Sabbatical, Training
• Yoga Teacher training • Travelling
- 2015 - 2018
Senior Compliance Manager
Morgan Sindall Professional Services AG (MSPS, seit 2019 BakerHicks GmbH)
• Team Lead and Coach for colleagues • Senior Consult in customer projects in Quality Management and Quality Assurance: Project Management, External Quality / Supplier Quality Management, Qualification / Validation • Supporting Business Development & Sales / Marketing • Trainer for GMP trainings for employees
- 2017 - 2017
Senior Quality Assurance Consultant
MSPS Projektassignment bei DSM Nutritional Products Pentapharm
Project assignement: Basic Engineering - Quality Assurance: • Coordination, creation and review of User Specification Requirements for a new HVAC system, Room Monitorin System, rebuilt of cleanrooms cGMP class B to D due to customer and project requirements • Leading meetings with project members and impacted customer members to achieve customer satisfied decisions and on time deliverables within project requirements for compliance to cGMP guidelines
- 2016 - 2016
External Quality Site Manager Solids and Packaging Europe
MSPS Projektassignment bei F. Hoffmann-La Roche AG, Basel, Schweiz
Project assignment: • Preparing Quality Agreement for an operational site in Italy • Performing evaluations for various Roche drug product process validations at a CMO in France on basis of Annual Product Quality Report data and creating related reports • Responsible for the creation of Knowledge Management for foreseen 16 products at a new CMO meeting internal stakeholders
- 2015 - 2015
Quality Assurance Manager
MSPS Projektassignment bei F. Hoffmann-La Roche AG, Basel, Schweiz
Project assignment: • Support of the Direct Material Specification Lifecycle Team in establishing and implementing new harmonized global process to implement global specification set-up for reduction of specification & material numbers which leads to decreased risks, simplified change mangement, and increased transparancy • Increase cross-functional collaboration with regard to responsibilities and accountabilities • Upstream stakeholder involvement
• Project Lead regarding Life Cycle Assessment (LCA) studies to establisch Carbon* and ECO footprints with aim to prioritise improvements on products or processes regarding the environmental effects; *global warming potential expressed in kg CO2 emission; • Sustainability strategy • Environmental Product Declarations
- 2008 - 2014
Global Quality Assurance Manager, Process Change Officer, Life Cycle Consultant
DSM Nutritional Products AG
- 2010 - 2011
Process Change Support Officer
DSM Nutritional Products Ltd
Change Management Projekt: • Facilitierung und Moderation von Arbeitsgruppen und deren Projekt-Besprechungen • Lenkung von Arbeitsgruppen zur Zielerreichung bestehend aus ausgearbeiteten Maßnahmen zur nachfolgenden Implementierung; Unterstützung von Workshops (z.B. Team Bonding, Interface, Challenge)
- 2008 - 2010
Global Quality Assurcance Manager Resale Items
DSM Nutritional Products Ltd.
• Lead Auditor with responsibility for 3rd Party manufacturer audits (Europe, USA, Cananda) due to cGMP for APIs, feed + cosmetic supplements, HACCP for food supplements, HSE, ISO 9001 requirements • Optimization of Supplier Qualification Process incl. Quality Agreement, Audit Report in DSM Quality System • QA Key Person in cross-functional project treams, QA Project Lead of integration ofof 150 products • Responsible for QC product specifications & final QA release and approval • Customer complaint handl.
- 2007 - 2007
Engineer Quality Assurance
Werthenstein Chemie AG (bis 200 MA) (Schering-Plough)
Qualitätsmanagement Dokumentation; Erstellung und Implementierung neuer abteilungsübergreifender Prozessbeschreibungen "Qualifizierung von Ausrüstungen" und "Versand von Material unter Quarantäne" inkl. Schulung aller Mitarbeiter; Ansprechperson für interne und externe Stakeholder wie unterschiedl. Abteilungen und Mutterkonzern Shering-Plough in U.S.A.
- 2005 - 2007
Sales Manager
Dolder AG (bis 60 MA)
Verkauf pharmazeutischer Wirkstoffe, fokussiert auf Onkologie, Schmerz, Muskelrelaxantien, Narkotika und Hormone inkl. Budget-Erstellung, Angebots-Erstellung, Preisverhandlungen u.a.; Beratung in Regulatory, Dokumentation nach cGMP, GMP-Audits, Lieferservice; Kunden in EU mit Hauptmärkten Deutschland + Österreich; Produktmanagement von Key-Lieferanten global (EU, China);
- 2001 - 2004
Produktverantwortliche, GMP-Verantwortliche
Sandoz Industrial Products GmbH (bis 450 MA)
Planung, Koordinierung und Überwachung der termingerechten Produktion (Sterilproduktion+Synthese) von Antibiotika; Projektmanagement bei Optimierungen und Neueinführungen; Aufbau + Leitung des Mitarbeiterschulungssystems; Durchführung von MA-Schulungen; Qualitätsverantwortung über Dokumentationserstellung, Qual/Val, Produktionsdurchführung + -dokumentation nach cGMP;
- 1999 - 2000
Technical Support Customer Specialist
Abbott Diagnostik GmbH (ca 2000 MA)
Wissenschaftlich-technische und anwendungsbezogenen Beratung von Kunden - Apotheken bis Blutbanken von Labor-Assistentin bis zum Professor - in Bezug auf Produkte, Nachweistest-Ergebnisse und Analysengeräte; Koordination des technischen Service Aussendienstes;
- 1994 - 2000
Head Technician, Research Technician, Technical Support Customer Specialist
Abbott Diagnostika GmbH
Ausbildung von Martina Schindek
- 1 Monat, Dez. 2017 - Dez. 2017
Lean Six Sigma Green Belt
Firebrand P.E.E. Cooperation
Certifcation of capability for Change Management and continual business improvement
- 1 Jahr und 5 Monate, Sep. 1998 - Jan. 2000
Wirtschaftswissenschaften
Fachhochschule Mainz
Controlling, Unternehmensführung
- 8 Jahre und 1 Monat, Sep. 1985 - Sep. 1993
Chemie
Technische Universität Darmstadt
Biochemie, Chemische Technologie
Sprachen
Deutsch
Muttersprache
Englisch
Fließend
Französisch
Grundlagen
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