Analytical Method Verification & Validation Expert

About the role

Antaes, a Swiss management and technology consulting firm, is recruiting on behalf of a client, a manufacturer of sterile pharmaceutical products for the US market, to strengthen its physico-chemical Quality Control laboratory in Zurich. The role starts as soon as possible.

Key responsibilities

• Write analytical method verification and validation protocols (method implementation plans) and the associated reports
• Lead method transfer and verification activities for raw materials and finished products
• Perform and support analytical testing for validation, investigations and change activities
• Manage laboratory investigations (OOS/OOT), deviations and CAPA
• Support the qualification and lifecycle management of laboratory equipment
• Prepare and review analytical procedures, qualification documents and laboratory SOPs

Required profile

• Degree in Chemistry, Analytical Chemistry or Pharmaceutical Sciences, or qualification as a Chemical Laboratory Technician or equivalent
• Several years of experience in pharmaceutical Quality Control under GMP
• Solid experience in analytical method transfer, verification and validation (ICH Q2) and in equipment qualification
• Rigorous, autonomous and able to quickly produce high-quality documentation
• Fluent English required; German is a plus
• Experience in a sterile or US FDA-regulated environment is a plus

Required skills

• In-depth knowledge of pharmaceutical analytical techniques (HPLC, GC, UV-VIS, FTIR)
• Method verification and validation (ICH Q2)