Superviseur en validation de méthodes analytiques - Pharmaceutique (H/F)

Analytical Methods Validation Supervisor - Pharma About us: Akkodis is an organization with more than 1,000 engineering, scientific and digital experts in Belgium. Our mission is clear: create a smarter future together! We are a one-stop-shop for engineering, IT, Life Science, and new technologies. Our combined passion for talent and technology allows us to look at the world differently. With our 360° offer we support companies in all sectors in implementing Smart Industry solutions, from the up and reskilling of entire teams to the delivery of complete projects. Our added value? We make incredible happen! What do you do all day? As Analytical Methods Validation Supervisor, you actively participate to the validation process of analytical methods, used in the QC department of a global biopharmaceutical company. You participate to the implementation of validation design, coordination of laboratory tests, data analysis and redaction of related documents linked to the validation of the analytical methods, subjected to cGMP standards. This function means that you will regularly interact several stakeholders of the validation project, like laboratory technicians, tests supervisors, validation manager, QA specialist, products coordinators, and others. It's a hybrid job that will allow you to combine work at home and on customer site. You will also be required to go to the laboratory when necessary (without performing any manipulation). This job lets you to start project management approach, while keeping a job with scientific thinking. You are also an integral part of Akkodis ''QC Analytical Methods’’ platform which means you'll have daily follow-up and support from people who know your work environment. Your responsibilities: As Analytical Methods Validation Supervisor, you are in charge to: o Participate to the reflection of the validation design and the treatment of experimental data in collaboration with different stakeholders. o Coordinate laboratory tests which can take place in various QC laboratories. o Write validation documents (validation protocols/reports, qualification protocols/reports, rational documents, comparability documents, revalidation assessment reports, etc.). o Participate to the investigation phases in case of acceptance criteria unmet. o Depending on your expertise, you may be required to participate to troubleshooting activity and decision-making with other customer experts. o Provide support to the management of quality elements (CAPA, eCC, Deviation, etc.), without being task owner. o Participate to the administrative tasks of the team (complete follow-up files, continuous improvement, etc.). o Guarantee the application and maintenance of adequate cGMP rules in his work area.

Your profile: o You are graduated as a master’s degree in pharmaceutical, bioengineering or chemistry. o You have a good knowledge in analytical methods validation. o Thorough knowledge of cGMP expectations. o You have advanced written and verbal communication skills. You are fluent in French and you have a good intermediate level in English. o You are organized, proactive, solution-oriented, open-minded, and flexible. o You enjoy meeting and speaking with people, presenting results by going straight to the point, and advising costumers. o Which can be seen as a plus: • You have laboratory experience to highlight, in tests such as HPLC, GC, RMN, spectrophotometry, ELISA, SDS-PAGE, viral potency assay, Western blot, cell counts, flow cytometry, or other related methods. • You have already used one of the pharmaceutical guidelines (ICH, USP, EP, etc.). • You have already used SAP and/or Veeva softwares.