QA Compliance Specialist for Laboratory (d/f/m)

Job Description Summary

Job Description

21+! This is the number of motivated and experienced colleagues you´ll be joining in our QA Compliance group as QA Compliance Specialist covering all GMP activities in our laboratories. Join us and become a key contributor to ensure our patients have access to medicines.

In this role you will take on the responsibility for the independent execution of compliance-relevant activities and quality-relevant activities, the implementation of regulatory and Sandoz requirements following the field of expertise and internal regulations, good practices, legislation and business objectives. You will also support risk management and inspection readiness and quality management activities.

Your position will play a key role as a QA Complince specialist in supporting various GMP activities in our 5 laboratories.

Your key responsibilities:

Your responsibilities include, but are not limited to:

• Ensure all activities comply with cGxP, incl. data integrity.
• Participate in deviation and OOX investigations, including corrective and preventive actions.
• Analytical procedures and verification/validation/transfer protocols and reports for analytical method procedures.
• Change control review/approval.
• Review and approve change controls.
• Audit and inspection preparation and support.

What you will bring to the role:

• A university degree in pharmacy, chemistry or other equivalent natural science degree is preferred.  
• Preferred working experience in quality functions on expert position production, development or other quality functions on expert position. 
• Functional knowledge in the English language and excellent command of Slovene.  
• Knowledge of Microsoft Office.  

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

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

You are kindly invited to submit your application in English or Slovene, including your CV, by February 17, 2025.

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