For our client – a globally renowned biotech CDMO in Visp, Switzerland – I am looking for a QC Project Lead to join a dynamic Small Molecule Drug Substance Unit!
Leads the introduction of new methods and processes into the Quality Control department via the technology transfer process, represents the department on project teams, and provides technical support during investigations.
Key responsibilities:
Provides input to program management regarding Quality Control capabilities and requirements for method qualification/validation.
Reviews applicable regulatory guidance and internal policy documents to ensure compliance.
Provides technical review of Statements of Work and Work packages to support contract manufacturing activities.
Provides Quality Control representation to project team meetings.
Responsible for relaying pertinent information such as production schedules and information requests to applicable Quality Control groups. Provides routine feedback regarding tech transfer and testing status.
Relays status updates in a timely and accurate manner.
Writes, reviews, and/or approves Method SOP/Forms, Sampling Plans, and Specifications.
Leads tech transfer activities related to Quality Control including generation of a Quality Control method transfer plan, method specific assay transfer protocols and reports, training plans, and project timelines.
Works in cooperation with TD to design qualification, and validation protocols.
May participate in the execution of such protocols as needed to support lab(s).
Assists with responses to audits, deviations, out of specification investigations, and corrective/preventative actions.
Performs other duties as assigned.
Key requirements:
Master degree or equivalent in Chemistry required.
Work Experience: Advanced Level in Quality Control 5-10 years.
Language: Preferably German, English must.
Experience in GMP, analytics for small molecules a must
Practicalities:
Location: Visp, Switzerland
Duration: 6-month contact – with a high of extension
Start-date: ASAP
Sound interesting? Send your CV to Khanyi Mabena at k.mabena@panda-int.com or contact her on +31 2020 44502.