Third Party Expert
Brabant Wallon – contracting
Life cycle & Change Control Specialist
What are your responsibilities?
- Develop further the process to prepare content on change controls for communication to external partners.
- Manage meetings with external stakeholders and present information to Quality, regulatory and technical collaborators
- Organize the transfer of information on change controls between GSK and QA department from external partner
- Collaborate with people located in MPU’s and abroad. Convince them vis-à-vis decisions, procedures or processes, while remaining diplomatic and maintaining motivation.
- Be able to manage internally (between colleagues from different departments) as well as externally.
- Efficient follow-up to respond to any questions and respect the timings of the projects.
- Establish & track key performance indicators for each step of the process
- Lead the design of or optimization of process
- Follow the implementation of changes and ensure alignment with RA and external partners to minimize the impact on supply continuity.
- Write local SOP with new process, and ensure training of all stakeholders (MPU, QA, QC, site conformance, RA, MSAT).
- Be responsible for the change controls specific to GSK working for an external partner
- Collaborate on punctual projects such as participation to taskforces, development of standards
Who are you ?
- Experience (preferable 5 years) in the following would be considered an asset :
- (Bio)pharma & cGMP
- Quality
- Project management
- Technical lifecycle
- Bilingual French/English (oral & written)
- Proactive with ability to identify and follow up on gaps in process
- Ability to work under pressure due to the requested flexibility and reactivity of the activities
- Be able to manage short term issues with long term activities in parallel.
- Ability to work in project teams in a multidisciplinary environment and a matrixial organization
- Be able to lead and manage cross-functional projects
- Excellent communication and negotiation skills
- Education, Methodology & Certification Requirements
- Scientific/Engineering degree (minimum BAC+4) (chemist or biochemist)
- ICT Skills (software,operating systems,hardware,etc.)
- SAP
- Microsoft Office (PowerPoint,Excel,Word)
What can you expect ?
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.
