Quality Assurance Specialist

Quality Assurance Specialist

Grünenthal Group

Origgio, Italy

What the job looks like

Each day you'll enjoy a variety of challenges, such as:

• Being part of the Quality Assurance team, reporting into the Head of QA Systems;
• Management of change controls;
• Participation in planning and execution of site trainings;
• Issuance and revision of Product Quality Review (PQR);
• Participation in planning and execution of self-inspections together with CAPA management;
• Revision of Master Batch Records;
• Issuance of process validation protocols and reports, participation in risk assessment management and cooperation in the revision of qualification and validation documentation;
• Overview on Quality Agreement with customers;
• Participation in management of regulatory aspects to maintain required manufacturing licenses;
• Collection of site KPIs.

What you'll bring to the table

To make the most of this role and truly thrive, you should have:

• Previous experience in a similar role within Quality Assurance departments (around 2 years);
• Comprehensive knowledge of GMP standards and a previous experience in change control, risk assessment management and process validation, basic knowledge of the local and international legal/regulatory requirements;
• Degree in Scientific disciplines;
• Fluency in English.

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