QA Compliance Specialist I (d/f/m)

Job Description Summary

Job Description

We are looking for QA Compliance Specialists to join our team of 7 people who will be responsible for the independent execution of compliance and quality-relevant activities related to Laboratory oversight.

Join us as a Founder of our ‘new’ Sandoz and Lek! 

Your responsibilities include, but not limited to:

• Ensure compliance with good practices, data integrity, and regulations (Slovenian, EU laws, Food and Drug Administration (FDA), International Council for Harmonisation Technical Requirements for pharmaceuticals for Human Use (ICH), The Pharmaceutical Inspection Convention (PIC) regulations).
• Analytical procedures and verification/validation/transfer protocols and reports for analytical method procedures.
• Laboratory oversight personnel training management and QA for Laboratory equipment.
• Pharmacopoeia compliance.
• Contract Testing Organization management and oversight.
• Support audits and inspections.
• Review and approve change controls.
• Participate in deviation investigations, including corrective and preventive actions.

Essential Requirements:

• 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 of 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, Slovenia.

We offer a permanent contract with a probation period of 6 months. You are kindly invited to submit your application, including your CV in English and Slovene, by 29.01.2025.

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

#Sandoz

Skills Desired