Martin Bach Andersen Email & Phone Number

Odense, Syddanmark, Danmark

Director for a department consisting of 4 managers and 31 FTE´s. Main tasks:• Design and implementation of a quality operating model and connecting it to the Quality Management System (QMS) - Result: Decrease of the lead time for release of products to the sales markets by 80%. • Responsible for the QP’s and RP to certify and release products according to GMP and GDP.• Responsible for authority inspections and customer audit.• Responsible for CMO contracts and performing supplier audits.

Odense, Syddanmark, Danmark

Project manager on the following pharma projects:• Configuration of Veeva QualityDocs, Training and QMS (Audit & Supplier Qualification)• Merger of the companies Pilatus Inc. and Pilatus Pharma Limited into Orifarm: - Aligning of QMS and SOP's - Integrating product supply chain, IT systems and legal entity setup - Authority certification

Virum, Hovedstaden, Danmark

• Design, installation and qualification (incl. FAT/SAT) of the waste treatment system and a vacuum catalytic oxidation system for LEO Pharmas new Fucidin® API facility.• Planning and scheduling all necessary ressources and activities: IT, utilities and power supply.

Region Sjælland, Danmark

Associate Manager in IM1 Recovery for 24 operators & 2 production planners.• Responsible for all production and quality processes at low pressure columns and harvest centrifuges.• Ensuring that the team were in compliance with SOP’s and GMP.• Creating focus on continuous improvements - what can be done by operators.• Lead person for developing and implementing the production plan incl. maintenance in ROB-EX.• Lead person for automation of process steps in the clarification and columns section.

Region Sjælland, Danmark

• Responsible for the fermentation process incl. its 23 operators and 1 production planner.• Creating tact in the production and optimization of the workflow of the operators in order to realize a reduction of the need for operators by 23%. • Handling of the shift plan.• Handling of accidents and near misses.• Ensuring that the team where in compliance with GMP.• Introducing systematic problem solving (A3) to the operators.• Continuous development of employee competencies

Kalundborg, Dapi Im1

• Responsible for designing energy saving – and major capacity projects for black and clean utility systems.• Handling of the time schedule and economy for projects.• Creating and executing on a validations strategy incl. Impact Assessment (IAR), Requirement Risk Assessment (RRA), User Requirement Specification and Technical Specification (URS and TS), Functional Specification (FS) and Design Qualification (DQ).• Creation of test and qualification strategy (IQ and OQ)• Supervision of suppliers and contractors to ensure equipment were delivered in compliance and on-time. Assignment in connection to management training:• Overall responsibility for all activities in a 3 week factory shutdown.• Campaign management of a shutdown group of 10 FTE’s.• Daily presentation of the shutdown plan for approx. 80 stakeholders.

Kalundborg

Responsible for process air and steam for the fermentation process in IM1.• Handling of all quality tasks related to Clean Utility e.g. deviations, change requests and qualifications.• Creating a preventive maintenance setup to ensure a reliable utility supply to the Insulin production

Maskinmester

Bachelor of Technology Management and Marine Engineering

Ubefaren Skibsassistent

Matematisk Linje