Posted: 24 April 2014 at 14:00 Expires: 22 May 2014 at 14:00
Posted In: Quality/Inspection > QA
Location: Belgium > Wavre
Role: R&D Quality System Consultant
Exciting 8 month contract opportunity to run until the end of 2014
Location - Wavre, Belgium
Job description
Leap29s client requires an experienced R&D Quality System Consultant to be placed on an exciting 8 month project for one of the world's leading research-based pharmaceutical and healthcare companies, concluding at the end of 2014.
Job Description
The correct candidate will be an instrumental part of developing and executing the Quality System Improvement Project Plan, which consist in the development and/or improvement of GXP process in R&D (Discovery to phase III). The objective of this QS Project Plan is to ensure Quality System Processes are defined and implemented, allowing continuous improvements.
Responsibilities
oSupport the development of transversal GXP process in R&D (Discovery to phase III) related to SOPs on SOPs
oTraining management
oArchive management
oDocumentation management
oChange management
oManagement Review (eg escalations principles and management oversight)
oSupport the implementation of Process Management, Lean and Continuous Improvement Strategies
oSupport and define the Business Process Modelling (BPM) and Continuous Improvement (LEAN) process
oEnsure support is provided to develop process documents that are in alignment with regulatory expectations and internal global policies and standards (QMS).
oEnsure state-of-the-art and best industry practices are reflected in our development with the company's R&D Quality System
Required Profile
oPreferably (master) LSS Black Belt or extensive training in BPM in pharmaceuticals
oExtensive (10 years) pharma/bio experience
oExtensive experience in developing R&D Quality Systems/Quality Management System (focus discovery and Phase I-II)
oBlack Belt preferred or extensive training in BPM in pharmaceuticals
oIn-depth knowledge of GXP (including non-regulated areas such as Good Research PracticeP/GoodSciencePractice) requirements (eg FDA, EMA, WHO, PICs) and experience of complex biological processes and if preferable, medical devices.
oMentoring capabilities, engaging and communicative personality
oAchiever, action oriented as immediate impact is expected
oHigh negotiation, diplomacy and influencing skills. Able to interact with peers, subordinate and senior personnel in multidisciplinary environment.
oAbility to lead the process to generate the exchange of ideas to resolve problems, prioritize solutions, select optimal solutions and implement decisions.
oPreferred French native speaking, with good English speaking.
To apply or for more information please do not hesitate to contact Angus McCormick at Leap29
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