$ads={1}
We are looking for a Pharma Sciences Subject Matter Expert (SME) for one of our clients based in Braine-l’Alleud.
Don't hesitate to contact me: siham.haddouchi@professionals.randstad.be
We are looking for a Pharma Sciences Subject Matter Expert (SME) for one of our clients based in Braine-l’Alleud.
Don't hesitate to contact me: siham.haddouchi@professionals.randstad.be
-
key responsibilities
Job summary:
Subject matter expert in DS, DP or analytical function) accountable for delivering assigned project work packages/transversal activities.
Participate in project sub-team (DS, DP or analytical) as SME representing own area of expertise providing input to support the elaboration of project strategy.
Work under little or no supervision to coordinate and manage activities internally and/or externally to deliver assigned work packages and toto design, plan, perform, interpret and report results of experiments in time to influence project decisions and next steps
Major Accountabilities:
Subject matter expert and trusted contributor in a specific area of DS, DP or analytical function working to appropriate standards of quality (GMP, GLP, GSP) ethics, health, safety, environment, protection and IT; Participate in continuous improvement initiatives.
Participate and contribute in DS, DP or Analytical project sub-team to support the elaboration of project DS, DP or analytical strategies by sharing information, plans and results and taking responsibility for designated tasks associated with own area of expertise.Under little to no supervision coordinate, manage and execute technical activities internally and/or externally for one or 2 assigned work packages to required quality, quantity, time and budget eg. DS/DP batch production, DS & DP process optimization, analytical method development & validation, stability program, route evaluation, form selection, material characterization…
Design experiments/trials and studies in accordance with Operating Model to support projects DS, DP or analytical development with little to no supervision.
Analyze and interpret own data to influence decisions and next steps. Collaborate & support laboratory technicians and scientists to deliver activities related to assigned work packages.
Author quality protocols and reports according to data integrity requirements to support regulatory filings.
Contribute to the transfer of know how to other departments or external contractors, including troubleshooting and on-site training.
Apply operating model to ensure the right things are done at right time relying on the strategy/guideline documents that will be embedded in the operating model.
Openly collaborate with other SMEs to ensure technical activities requiring support from other teams or functions can be supported transversally and delivered to plans.
Support DS, DP or analytical PL by providing resource and timelines for specific activities.
Openly communicate new risks, deviation from forecasted plans to DS, DP or analytical PL and sub-team members.
Provide support related to area of expertise in audits and health authority’s inspection as required.
Collaborate & support/mentor laboratory scientists in execution of experimental work.
Contribute to departmental goals & priorities in a collaborative manner.
Contributes to departmental technical & scientific objectives as it relates to own area of expertise
Contribute to Pharma sciences innovation, Science & technology projects as it relates to own area of expertise.
Maintain up-to-date knowledge of own area of expertise and participate in academic collaborations, scientific conferences and as a contributor to scientific publications, presentations and patents
Communicate, address and solve problems within own area of expertise as they arise, identifying and implementing innovative solutions to resolve them.
-
qualifications
Education:
Bachelor’s Degree
Experience:
Minimum 2 years relevant experience in pharmaceutical industryUnderstanding of GMP and regulatory requirements
Competencies:
Problem Solving
Use scientific expertise to design technical experiments with minimal guidance depending.
Problem solving mindset. Ability to propose solutions and/or seek for inputs/advices within the team or beyond own function.
Able to interpret results, build new experimental hypotheses with a balanced approach to risk taking.
Considers the balance between efforts, risks and benefits when resolving challenges
Business / Transformation Impact
Demonstrated ability to collaborate effectively across teams within own department.
Able to take courageous and balanced risks adopting a risk based approach to own activities
Interested in learning about area outside own expertise, projects, platforms, technologies and regulations to influence own work.
Planning & Organization
Proactive, self- motivated and autonomous working style and able to manage own activities under minimal supersion/guidance.
Some project management abilities needed to coordinate/manage activities internally/externally and to forecast resources and timelines.
Functional & Technical Knowledge
Sound technical expertise in a specific area of DS, DP or analytical development.
Curious mindset with an interest in new technologies
Knowledge of GMP and regulatory requirements for area of expertise
Some project management and risk management required
Communication & Influence
Good communication and presentation skills and able to convey information in a clear and concise manner to write clear instructions, protocol and reports.
Openly share information with team and management.
Able to build collaborative relationships and has a can-do mind-set
Able to manage and prioritize own tasks with little supervision or guidance
-
key benefits
Consultancy
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.
