(Senior) QA Specialist Qualification (6468)
(Senior) QA Specialist Qualification – 6468 ASH
Our client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is looking for a (Senior) QA Qualification Engineer based in Visp, Switzerland for a contract role with possible extension.
Main 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
Qualifications and Experience:
- Relevant working/residency permit or Swiss/EU-Citizenship required.
- 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
- Fluency in both English & German