QA Compliance Specialist (d/f/m)

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Sandoz, CA, USA
In-Office
Biotech • Pharmaceutical
The Role

Job Description Summary

The future is ours to shape.


 

Job Description

We are looking for a motivated QA Compliance Specialist, who will be responsible for independently performing control and approval activities for analytical procedure validations, deviations, and support in the implementation of qualifications and validations. You will also be responsible for reviewing and approving documentation related to the quality control of our products.

Your key responsibilities: 

Your responsibilities include, but are not limited to:

  • Ensuring that all activities comply with current good practices (cGxP) and data integrity.
  • Participating in the development, implementation, and control of the quality system and managing implementation in accordance with Slovenian and European legislation, FDA, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, the Pharmaceutical Inspection Convention, and Sandoz standards.
  • Support in qualification and validation activities (planning, consulting, review).
  • Review and approval of changes.
  • Participation in investigations regarding deviations and complaints, management of corrective and preventive actions, and tracking of implementation.
  • Preparation and support for audits and inspections.
     

What you will bring to the role: 

  • Preferred university degree in pharmaceutical, chemical or other natural science field.
  • Preferred work experience in laboratory, production, development or other professional experience in the field of quality.
  • Active knowledge of English and Slovenian language.
  • Good communication skills and the ability to take responsibility for your work.

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: Lendava (Slovenia)

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 CV by May 5th, 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 #BioRampUp


 

Skills Desired

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The Company
HQ: Basel
110,000 Employees
Year Founded: 1996

What We Do

Novartis is an innovative medicines company. Every day, working to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide.

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