Feb 27, 2024

About the Role

Location: Mengeš #LI-Hybrid

We bring life-saving medicines to millions of people. We are at the crossroads of the latest advances in medical science and innovative digital technology. Everything we do is in line with our commitment to quality and to providing safe active substances for patients. Our commitment to quality is based on science, we innovate and our work is patient-centered. Whether you are involved in development, production, maintenance, compliance or analysis, your contribution will have a direct impact on patients. ” Without quality checks and quality assurance at all points in the process, we cannot reliably build patient trust. Do you value this mission?

As the QA Compliance Expert, you and your colleagues ensure that GMP compliance requirements are met. Your role involves taking the initiative, coordinating and implementing all the necessary activities to achieve compliance. In this role, you also have an advisory role on GMP matters for all employees in the value stream.

Key Responsibilities:
• Ensure all activities in compliance with cGxP, and with data integrity.
• Support site qualification and validation activities (planning, advising, review).
• Implementation of Quality Systems (incl. documentation management and internal auditing).
• Preparation, support and coordination of Corrective and Preventive Actions (CAPA) follow-up.
• Audit and inspection preparation and support.
• Change control review and approval.
• Drive process optimization, continuous improvement, operational excellence, innovation, proactive compliance.
• Mentoring and transfer of knowledge within as well outside the team.

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Role Requirements

Essential Requirements:
• University degree in pharmacy, biology, chemistry, microbiology other equivalent natural or engineering science degree.
• Minimum 3 years of working experience in production, development or other quality functions on expert position.
• Functional knowledge of English.
• Knowledge of Microsoft Office.

We offer permanent employment, with 6 months of probation period.

You are kindly invited to submit your application in English language, including CV by 31st of December 2023.

Why Novartis?
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn morehere: https://www.novartis.com/about/strategy/people-and-culture

You’ll receive:
Competitive salary, Annual bonus, Flexible working schedule, tailored to your needs, possibility to work from home, Pension scheme, Employee Recognition Scheme, Expanded program for the promotion of health in the field of physical, mental and social well-being (Energized for Life), employment at Top SI Employer, Unlimited learning and development opportunities.

Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

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

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Full Time
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QA Compliance Expert (m/f/d)

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