QA eCompliance Expert (d/f/m)

Job Description Summary

Job Description

21+! This is not just a number, but the incredible team of passionate and skilled individuals waiting to welcome you to our QA Compliance group as a QA eCompliance Expert. Join our team and make a meaningful impact by ensuring that our patients have access to the vital medications they need.

We are looking for two QA eCompliance Experts, who will have the opportunity to contribute to various projects, making their role essential to our success.

Your expertise and support will be highly valued as we strive to maintain compliance and meet industry standards. Join our team and play a key role in ensuring the quality and compliance of our GxP computerized systems, contributing to our commitment to excellence and the access to medications for the patients we serve.

Your key responsibilities:

Your responsibilities include, but are not limited to:

• Ensuring all activities comply with cGxP, incl. data integrity.
• Audit and inspection preparation and support.
• Change control review/approval.
• Ensuring local DI and eCompliance oversight (training, inspections, plan, risk ID etc.).
• Provide quality assurance expertise/guidance for GxP computerized systems classification, qualification, supplier assessment, change control, deviation management and associated activities that ensure regulatory and company expectations compliance.
• Reviewing and approving the determination of the computerized system for GxP applicability.
• Performing life-cycle activities of the GxP computerized systems in scope (e.g.: periodic reviews, change controls, deviations management, risk mitigations) including review & approval of relevant documentation and its maintenance according to the Sandoz requirements.
• Performing timely support for projects.

What you will bring to the role:

• University degree in chemistry, biology, computer science, or other relevant life sciences.
• At least 5 years of experience in automation/CSV or a minimum of 5 years of laboratory experience.
• Functional knowledge of English and fluency in the Slovene language.
• Proficiency in Microsoft Office tools.
• Strong motivation for work, independence, self-initiative, and excellent communication skills.
• Reliability and strong decision-making capabilities.

You’ll receive:

Employment at the most reputable employer in Slovenia offers 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), Unlimited learning and development opportunities. 

Possible job locations: Ljubljana or Lendava

We offer permanent employment, with a 6-month probation period.

You are kindly invited to submit your application in the English or Slovene language, including your CV by the 25th  of November 2024.

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!

The future is ours to shape!

Commitment to Diversity & Inclusion:
Sandoz is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve. 

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

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Skills Desired