QA Specialist II
(Senior) QA Specialist Qualification (f/m/d)
We are currently seeking a highly skilled and dedicated QA Specialist Qualification to join our client's BIO Biologics Division Services (BDS) Department.
Key Responsibilities:
Representing QA Qualification in the project organization for new facilities or other projects, focusing on the qualification of facilities, utilities, equipment, and systems.
Coordinating different QA interests during the project phase, including process, cleaning, and other relevant QA objectives.
Driving the implementation of new qualification strategies and acting as a strong decision-maker when needed.
Compiling, reviewing, and releasing Qualification Documents (e.g., URS, Qualification Plan & Report, DQ/IQ/OQ/PQ Reports) and supporting/approving quality risk analyses (e.g., FMEA).
Performing assessments and approvals of technical change requests throughout the project and lifecycle, evaluating their impact on the qualification of facilities, equipment, utilities, and systems.
Representing qualification topics during customer audits and regulatory inspections.
Overseeing CAPA and Effectiveness Checks to ensure timely completion and proper closure, and ensuring deviations are thoroughly investigated and recorded in Deviation Reports.
Key Requirements:
Bachelor's degree in Engineering, Chemistry, Biotechnology, or a related field.
Significant experience in qualification within the pharmaceutical industry.
Strong understanding of applicable cGMP regulations (an advantage).
General knowledge of engineering and manufacturing processes.
Ability to oversee project execution and identify non-compliance with quality standards.
Fluent in both German and English (written and spoken).
For further information about this position, please apply with your CV.
Please note, only candidates who are authorized to work in Switzerland (e.g., Swiss nationals, EU/EFTA citizens, or individuals with a valid work permit) will be considered for this position.