QA Qualification Engineer - 6345 ADA

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Senior Recruitment Consultant at 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.

Main Responsibilities:

• Hold all quality related responsibilities for daily qualification activities on technical facilities, equipment and systems.
• Support the development, review and release qualification documents.
• Assess and approve change requests regarding their relevance to the qualified state condition and ensure this supports and approves quality risk analysis (e.g. GMP-FMEA).
• Ensure that deviations are appropriately investigated and addressed in deviation reports processed in deviation reports QA activities follow legislation, authority and customer expectations.
• Inform the Group Manager QA Qualification about relevant developments and trends.
• Actively support the formulation and further development of qualification strategies and continue to train accordingly.
• Support internal audits in accordance with the internal audit plan, at customer audits and official inspections as QA representative.

Qualifications and Experience:

• Relevant working/residency permit or Swiss/EU-Citizenship required.
• Experience in biotechnology or pharmaceutical environment.
• Experience as QA Qualification.
• Knowledge on FAT/SAT/IQ/OQ/PQ.
• Proactive, with good communication skills and can work in a multidisciplinary team towards a common goal.
• Fluent in English (spoken and written).
• Experience in risk analysis.
• German speaking.
• Knowledge of SAP, DMS, Trackwise is a plus.

Seniority Level

Not Applicable

Employment Type

Contract

Job Function

Engineering and Quality Assurance

Industries

Pharmaceutical Manufacturing