QA Specialist (w/m/d)

QA Specialist Qualification (w/m/d)

Location: Visp, Switzerland

Duration:

Key Responsibilities

• Representative of QA Qualification in the project organization for new facilities or other projects in regard to qualification of facilities, utilities, equipment and systems
• Coordinating different QA interests during the project phase e.g. process, cleaning or other relevant QA objectives
• Driving implementation of new qualification strategy and being a strong decision maker when needed
• Compiling, reviewing and releasing Qualification Documents (URS, Qualification Plan & Report, DQ/IQ/OQ/PQ Reports and more) as also supporting and approving quality risk analysis (e.g. FMEA)
• Performing assessments and approvals of technical change requests during the different phases of a project and lifecycle and their relevance to the qualification of facilities, equipment, utilities and systems
• Representing qualification topics during customer audits and regulatory inspections
• Being responsible to drive CAPA and Effectiveness Checks to completion and timely closing as well ensuring deviations are appropriately investigated and recorded in Deviation Reports

Key Requirements

• Bachelor degree in Engineering, Chemistry, Biotechnology or a related field
• Significant experience in qualification within the pharmaceutical industry
• Good understanding of the applicable cGMP regulations would be an advantage
• General knowledge of engineering and manufacturing processes
• Ability to oversee project execution to identify non-compliance from quality standards
• Fluent language skills in German and English is required

In Switzerland, for contract roles it is mandatory for the candidate to be a Swiss citizen or a European passport holder.

Sthree Switzerland is acting as an Employment Business in relation to this vacancy.