Tobias Kuners of Koenders partly available

Tobias Kuners of Koenders

Pharmazeutischer Compliance Engineer consultant

partly available
Profileimage by Tobias KunersofKoenders Pharmazeutischer Compliance Engineer consultant from EttenLeur
  • 4873 BP Etten-Leur Freelancer in
  • Graduation: 1986
  • Hourly-/Daily rates: 150 €/hour 1200 €/day
  • Languages: German (Full Professional) | English (Full Professional) | Dutch (Native or Bilingual)
  • Last update: 03.04.2019
KEYWORDS
PROFILE PICTURE
Profileimage by Tobias KunersofKoenders Pharmazeutischer Compliance Engineer consultant from EttenLeur
ATTACHMENTS
Kurze Beschreibung des letzten Projekts
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Englischer Lebenslauf
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SKILLS
  • Project - & Portfolio Management
  • Quality – & Regulatory Compliance Systems Design & Review
  • Predictive -, Preventive -, Corrective Maintenance
  • Validation Documentation Drafting, Reviewing, Executing
  • PQR Documentation Drafting & Reviewing
  • Executing, Reviewing and Reporting of Validation Tests
  • Working in strict cGMP environment
  •  
  • Training Curricula Design, Develop & Present
  • Change Management
  • Coaching & Mentoring Junior, Medior, Senior & Executives
  •  
  • GMP / GDP
  • EMA / FDA
  • ISO / ASTM
  • CQV, Maintenance, Reliability
  • Lean Six Sigma / Operational Excellence
  • Industrial Master Planning
  • Turn Around Management
  • MS Windows & MS Office (Word, Excel, PowerPoint, Outlook, SharePoint)
  • TrackWise
REFERENCES
Project Manager for a Radiopharmaceutical Company in Germany to make a business assessment and project proposal [Capital Approval Request] for the extension of the existing facility and a Greenfield development.
Regulatory Expert for Medical Oxygen Infrastructure in Emergency Response Aircrafts for an Aircraft Emergency Medical Interiors Company.
Project Manager for an RCO in Hungary to design & develop a training for Eudralex Annex 13 (Investigational Medicinal Product).
Facility, Maintenance, Engineering Director a.i. for Patheon Biologics, in a transition from a largely clinical CMO to a mostly commercial CMO; Driving Change for the Technical Organisation directly and for the Organisation at large indirectly, heading for full Commercial CMO. Supplier Qualification for Equipment, MRO parts, and services such as Clean gases, Pest Control, Cleaning, and Maintenance. Project lead for Engineering to eliminate 120+ days and reduce the 90+ days and 30+ days open observations, deviations, and capa’s.
With the focus on the challenges of acquiring and integrating human capital during rapid growth while managing risk in relation to variable costs, maintaining quality, and preparing the organisation for deliverability of products and services to support the growth of the company.
Project Lead for maturing the existing QMS to be inspection ready for FDA, and EMA Inspection, with initial assessment, GAP Analysis and closure program.
Material Expert and Project Manager through Quanta CS for the GxP complaint Retirement of a Pharmaceutical Sterile Manufacturing Facility in the South of the Netherlands.
Subject Expert and Consultant for Quality Executive Partners (QxP) on Facilities, Engineering, Maintenance, Calibration, Utilities, Packaging, Extractables & Leachables for a Quality Management Systems Harmonization Initiative with a Major Pharmaceutical Company in Europe integrating a recently acquired vaccines Business Unit.
Expert and PMO-Coordinator for the GMP-Compliant Retirement of a Manufacturing Facility in Germany for a Renowned Multinational Company.
Pharmaceutical Compliance Subject Matter Expert for QxP in Germany for Warehouse and Transport, Equipment Qualification and Commissioning for Warning Letter Remediation with a Major German Pharmaceutical Company.
Executive Coach for a Managing Director from a Dutch Construction Company during a Major Transition Initiative.
Project Manager/Change agent through Progress-PME in the Netherlands for Procurement, Warehouse & Distribution, Supply Chain, Secondary Packaging and associated Business IT systems (SAP, LIMS) for a Plasma Pharmaceutical Company experiencing a 5-fold growth of its manufacturing capacity. Supplier Qualification for Raw Materials and MRO parts.
Engineering Manager a.i. with Danone Group/Nutricia at their Medical Nutrition Manufacturing Site in the Netherlands.
  • Led Engineering department and Project Management Office, a team of 17; comprising Sr. Project Managers, Project Engineers, Process Engineers, Industrial Automation Engineers, and draftsmen. Providing Departmental Leadership, implemented Project management rigour for Capital Investment proposing, Tendering and Execution; covering Civil, Utilities, Liquid Processing, Filling & Packaging, and Palletizing.
  • Led department with projects for a new building; liquid processing equipment, and filling & packaging lines. Two aseptic pouch lines with up-stream processing equipment building expansion for new blow-moulding equipment; Several smaller projects for new bottle format; for new spout format; multi-line, multi-format palletizer & wrapper.
  • Project Lead for maturing the existing QMS to be inspection ready for FDA, EMA, and JP Inspection, with initial assessment, GAP Analysis, and GAP closure program.
  • Supplier Qualification for Equipment, MRO parts, and services such as Clean gases, Pest Control, Cleaning, and Maintenance.
  • Project lead to eliminate 120+ days and reduce the 90+ days and 30+ days open observations, deviations, and capa’s.
Mentor & Coach for students in a minor for Prince2 Project Management during a practical term assignment with a Major Multinational in the Netherlands
Consultant in a tender process for Engineering, Maintenance & Facilities Services for a large academic hospital in the Netherlands.
TIME AND SPATIAL FLEXIBILITY
Ich bin von Montag bis Freitag verfügbar vor Ort, aber ich möchte am Wochenende für meine Kinder zu Hause sein.
Ich kann flexibel sein, wenn es darum geht, das zu tun, was getan werden muss.
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