Pharmaceutical Company
Description:
We are looking for a (Senior) QA Specialist Qualification (f/m/d), who will support our team QA plant qualification.
Key Responsibilities
1. Representative of QA Qualification in the project organization for new facilities or other projects in regard to qualification of facilities, utilities, equipment and systems.
2. Coordinating different QA interests during the project phase e.g. process, cleaning or other relevant QA objectives.
3. Driving implementation of new qualification strategy and being a strong decision maker when needed.
4. 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).
5. 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.
6. Representing qualification topics during customer audits and regulatory inspections.
7. 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
1. Bachelor degree in Engineering, Chemistry, Biotechnology or a related field.
2. Significant experience in qualification within the pharmaceutical industry.
3. Good understanding of the applicable cGMP regulations would be an advantage.
4. General knowledge of engineering and manufacturing processes.
5. Ability to oversee project execution to identify non-compliance from quality standards.
6. Fluent language skills in German and English is required.
Contact: Alba Jansa
alba.jansa(at)experis.ch / Whatsapp:+41 76 811 63 99
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