For our client, a biotechnology company leader in its field, we are currently looking for a
QA Associate - Delegated Responsible Person
When acting as a delegated Responsible Person (according to Swiss Ordinance 812.212.1), you are authorized to give directives (also towards management) in your area of responsibility for the company HQ, and as well as for the manufacturing plant.
Main responsabilities :
* Release and disposition of API, DS, DP for commercial and clinical Large Molecules/Small molecules products.
* Release of FG products.
* Ensure compliance for materials manufactured with respect to regulatory and GMP requirements.
* Further responsible for (but not limited to) review and verification of batch release documentation.
* Follow up with GEQ colleagues and cross-functional departments (i.e. EM, Logistics, Planning) on batch status, deviations, changes and CAPAs related to the batch documentation.
* Give advice on regulatory and compliance question to stakeholders.
* Review and perform QA approval on release relevant documents, Deviations, CAPAs, Change-Controls.
* Participate as a GEQ Release representative on cross-functional teams and projects with regard to the release process.
* Master Degree / Bachelor Degree in scientific field + 5 years? experience in relevant industry or equivalent.
* Experience in the pharmaceutical (small molecules or biotechnology) industry
* Strong knowledge of cGMP requirements, EU/FDA regulations and compliance
* Experience in clinical trials and/or regulatory is an asset
Are you willing to join a fast-growing company and take your carreer path to the next level ? Do not hesitate to apply !