Analytical Method Validation Lead – GMP QC, ICH Q2

Antaes Consulting; Zürich; On-site; CHF 90,000 - 120,000; Full time

Job summary

Antaes is seeking an Analytical Method Verification & Validation Expert to join its physico-chemical Quality Control laboratory in Switzerland. You will write verification/validation protocols, lead method transfer, and support testing for validation, investigations and change activities.

The ideal candidate holds a degree in Chemistry or Pharmaceutical Sciences, has several years of GMP QC experience, and is proficient in HPLC, GC, UV-VIS and FTIR with a strong bias for meticulous

Qualifications

• Degree in Chemistry, Analytical Chemistry or Pharmaceutical Sciences
• Several years of GMP QC experience
• Experience in method transfer/verification/validation (ICH Q2)
• Equipment qualification knowledge
• Knowledge of HPLC, GC, UV-VIS, FTIR
• Experience in sterile or US FDA-regulated environment is a plus
• Rigorous and autonomous; produces high-quality documentation
• Fluent English; German is a plus

Responsibilities

• Write analytical method verification and validation protocols (method implementation plans) and 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 qualification and lifecycle management of laboratory equipment
• Prepare and review analytical procedures, qualification documents and laboratory SOPs

Skills

GMP QC experience

Method transfer

Analytical method verification

Analytical method validation

ICH Q2 knowledge

Equipment qualification

HPLC

GC

UV-VIS

FTIR

Documentation discipline

Fluent English

Education

Chemistry degree

Analytical Chemistry

Pharmaceutical Sciences degree

Chemical Laboratory Technician

Tools

LIMS

ChemStation

Job description

Antaes is seeking an Analytical Method Verification & Validation Expert to join its physico-chemical Quality Control laboratory in Switzerland. You will write verification/validation protocols, lead method transfer, and support testing for validation, investigations and change activities.

The ideal candidate holds a degree in Chemistry or Pharmaceutical Sciences, has several years of GMP QC experience, and is proficient in HPLC, GC, UV-VIS and FTIR with a strong bias for meticulous