QA for Qualification and CSV

Hobson Prior are currently looking for a QA for Qualification and CSV to join a brilliant pharmaceutical organisation on a permanent basis located in Basel. Our client is focused on developing, producing and testing future solutions.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• For this position, you will be accountable for QA connected tasks regarding data integrity, electronic records management, recovery and back up method.
• Guarantee re-qualification actions and e-validation of computerised systems.
• Serve as a representative for QA in CAPEX, qualification and CSV-linked projects, as well as contribute to the site qualification and CSV actions and respective methods.
• You will drive data integrity assessments.
• Evaluate and approve the qualification and CSV documents of the facilities/equipment/utilities and computerised systems as outlined in SOPs.
• Manage QA for all qualification, CSV and DI concerned deviations, changes and CAPAs.
• Contribute to the risk analysis of facilities, equipment, utilities and computerised systems and assist respective classification into GMP/non-GMP.
• Any other assigned duties.

Requirements:

• Educated to an advanced degree level in a life science or similar field.
• Familiarity within a GMP-regulated setting for drug product manufacturing or testing, experience in aseptic production would be advantageous.
• Demonstrable experience in qualification, Data integrity and CSV.
• Expertise in GMP within all pertinent national, EU and US guidelines.
• Prior involvement with data integrity in Pharma and ERP systems, as well as deviation and change process.
• Acquaintance with monitoring execution of an MES as well as releasing drug product to market would be beneficial.
• Fluency in both German and English.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

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