Dr. Robert Eifler

Berufserfahrung von Robert Eifler

• Bis heute 5 Jahre und 6 Monate, seit Jan. 2019

  Global Material Qualification Specialist

  Takeda

• 1 Jahr und 3 Monate, Nov. 2017 - Jan. 2019

  Global Material Qualification Specialist

  Shire Austria GmbH

  Lead in a matrix; Manage and assess all material related process changes globally; Plan and execute MQ packages acc. to regulatory guidelines; Own E&L and CCI programs; Support CMOs, internal projects and local facilities through material’s lifecycle (select, implement, qualify, submission, change management); Strengthen relationship with supply chain and internal customers; Maintain knowledge of standards and literature (BPSA, BPOG, PDA), share knowledge with global network and apply it to procedures

• 1 Jahr und 5 Monate, Juli 2016 - Nov. 2017

  Process Validation Supervisor

  Shire

  Lead and inspire team (6-8) of Clean Validation and PPQ experts to develop and implement validation strategies for investigational and commercial drug products. Provide coaching, on-the-job training, resource planning and management through change. Facilitate communication with strategic partners, drive continuous improvement, participate in audits, support licensure and establish a bench-scale lab for clean processes. Act as SME and rep. to harmonize best-practices across Shire acc. to industry standards.

• 1 Jahr und 3 Monate, Mai 2015 - Juli 2016

  Procss Validation Supervisor

  Baxalta

• 1 Jahr und 9 Monate, Sep. 2013 - Mai 2015

  Process Validation Supervisor

  Baxter in Österreich

• 3 Jahre und 4 Monate, Juni 2010 - Sep. 2013

  Process Quality Assurance - Validation Specialist

  Baxter in Österreich

  Implement validation requirements according to internal and external guidelines and provide GMP support for investigational and commercial products including process transfer and process, lifetime (chromatography resins and UFDF membranes) and transport validation using QbD principles (RACT, PFMEA). Conduct quality system and validation training, provide oversight for change management and non-conformancy reporting, participate in audits, support licensure and serve as SME for process validation and MQ.

• 3 Jahre und 1 Monat, Sep. 2006 - Sep. 2009

  Research assistant

  Medical University of Vienna

  Acting study director responsible for the study design, coordination and execution, resource management, donor recruitment, development of system and methods, performing cell and molecular biology techniques, data analysis and interpretation and communication of results.

• 2 Jahre und 7 Monate, Feb. 2004 - Aug. 2006

  Process and Product Development Engineer

  Boston Scientific Corporation

  Characterized and mitigated field failures, maintained product compliance, performed process development and transfer to production, equipment qualification, process validation and student mentorship.