Direct message the job poster from CTC Resourcing Solutions
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 QA Qualification Engineer based in Visp, Switzerland for a contract role with possible extension.
(Senior) QA Specialist Qualification - 6468
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
* Fluent language skills in English and German
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Quality Assurance
Industries
Pharmaceutical Manufacturing and Biotechnology Research
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