SME Drug Product Expert
il y a 1 mois
We are looking for a SME Drug Product Expert for one of our clients in the pharmaceutical sector based in Braine-l'Alleud.
This is a contract as Consultant (employee or freelance) starting in June 2024 and ending 31th, December 2024 with possible extension.
key responsibilities
As SME Drug Product Expert, your main tasks and responsibilities will be:
•Subject matter expert and trusted partner in DP function working according to appropriate standards for quality (GMP, GSP and GLP), ethics, health, safety, environment, protection and IT; leading functional initiatives to ensure continuous improvement.
•Contribute to DP project sub-team to the elaborate project DP strategies by proactively sharing plans, information, data and conclusions and taking full responsibility for all designated tasks associated with own area of expertise.
•Autonomously coordinate and manage technical activities for assigned work packages internally and/or externally to required quality, timeline and budget eg. DP clinical campaigns, DP process optimization, stability program, route evaluation, form selection, material characterization, ...
•Design experiments/trials and studies in accordance with Operating Model to support projects DP development in an autonomous manner.
•Evaluate and interpret data with different degree of complexity, draw relevant conclusions; openly collaborate with laboratory technicians and scientists to deliver activities for assigned work package; perform complex tasks without having established procedures.
•Work according to appropriate standards following the principles of Quality by Design (QbD).
• Autonomously write high quality source documents including experiment plans, protocols and reports according to data integrity requirements to enable regulatory filing. Support department with the review of protocols and reports from other SMEs.
•
qualifications
As SME Drug Product Expert, we expect the following competences and skills:
Bachelor's degree/ Master's degree/ Ph.DUse scientific expertise to design technical experiments independently/autonomously in order to resolve complex problemsProven ability to critically interpret results, build new experimental hypotheses, and take calculated risks and smart decisions. Coaches and encourages team members to adopt risk-based approach to own activities. Business / Transformation Impact:Demonstrated ability to collaborate effectively across teams within and beyond own departmentProactive, self- motivated and independent working style and able to manage own activities independently/autonomously to drive smart decisionsExcellent ability to build collaborative relationships and a can-do mind-setA mind-set of curiosity, creativity, collaboration and openness to diverse thinking, with an enthusiasm to develop self and others. Planning & Organization:
Proven ability to manage and prioritize multiple tasksSignificant project management abilities needed to coordinate/manage activities internally/externally and to forecast resources and timelinesAutonomous working style and able to manage activities for multiple work packages. Functional & Technical Know-How:
Proven and recognised technical expertise in a specific area of DP developmentShow interest in learning about area outside own expertise, projects, platforms, technologies and regulations to influence own work and departmentUp to date knowledge of GMP and regulatory requirements within area of expertise.Very good project management and risk management required Communication & Influence :
Excellent communication and presentation skills with the ability to convey information in a clear and concise manner to write clear instructions, protocol and reportsTrusted partner within own department with influence beyond own department and PS.Proactively and openly shares information with team and management group. Able to present complex information in a concise and clear manner.Attitude to resolve challenges with the ability to accurately balance between efforts, risks and benefits. key benefits For this position of SME Drug Product Expert, we offer an attractive salary with extra-legal advantages: Group insurance Hospitalisation insurance Meal vouchers of 7 euros gross per working day Reimbursement km or company car Monthly allowance (80 euros net per month) A 13th month Training Etc. A rate as a freelancer is also possible.
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