QA Specialist II_CH

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

Contact: Alba Jansa

alba.jansa(at)experis.ch / Whatsapp: +41 76 811 63 99