Major accountabilities:

• Support technological and organizational interventions aimed at the improvement of manufacturing processes in terms of quality, productivity and costs and the optimization of the resources relating to the site.
• Ensure that the company manufacturing objectives and policies are consistent with GMPs.
• Support the development and implementation of projects related to new or existing products.
• Approve/verify the documentation (batch record, specifications, sampling and control methods, procedures of the Quality Management System, protocols).
• Ensure the update of the lists of documents related to the Quality Management System based on the indications of the reference SOPs.
• Draft Annual Product Quality Review and collaborate in drafting of Site Master File.
• Manage the product complaints, CAPAs and change controls.
• Review and approve the investigations in case of analytical results out of specification (OOS), out of trend (OOT), out of expectation (OOE) or System Suitability Test failures.
• Support the preparation and execution of internal audits and Health Authorities inspections and the execution of Self Inspections.
• Manage the Supplier Qualification.

Essential requirements:

• Scientific Degree.
• Previous experience within the Quality Assurance department of a pharmaceutical/biotech company.
• Clear and effective communication skills.
• Fluent in Italian and English.
• Willing to relocate to Saluggia with the flexibility of working from home 1x/week.