Quality Assurance Specialist

Novartis Italia; Saluggia; Ibrido; EUR 35.000 - 55.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company in Saluggia is seeking a QA Specialist to manage projects in the Quality Assurance department, ensuring GxP compliance and optimizing manufacturing processes. Ideal candidates hold a scientific degree and have experience in the pharma/biotech industry. Fluency in Italian and English is required. This role offers a supportive work environment with the option to work from home once a week.

Competenze

• Previous experience within the Quality Assurance department of a pharmaceutical/biotech company.

Mansioni

• Support improvements in manufacturing processes regarding quality and productivity.
• Ensure company objectives align with GMPs.
• Manage the product complaints, CAPAs and change controls.

Conoscenze

Clear and effective communication skills

Fluent in Italian

Fluent in English

Formazione

Scientific Degree

Descrizione del lavoro

Summary

The QA Specialist manages all aspects and projects within the Quality Assurance department. They guarantee and support GxP conformities and Novartis Quality System.

About The Role

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.

Why Novartis

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

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Benefits and Rewards

Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards