Dipl.-Ing. Martina Schindek

• Designee of FvP/QP and responsible for Cricital Quality Notifications, Quality Action System management, supporting FvP/QP declarations and market release • Lead Auditor for self inspections • QA key person in transfer projects of products and processes focussing on Quality Agreements • Responsible for optimization and improvement of QA processes

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)

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)

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

60 - 80 % working time 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

• 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

• Yoga Teacher training • Travelling

• 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

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

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

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

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)

• 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.

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.

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);

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;

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;

Controlling, Unternehmensführung

Biochemie, Chemische Technologie