QA Operations Specialist I (d/f/m)

Job Description Summary

Job Description

40+ is the number of different molecules we are responsible for through careful implementation and maintenance of quality standards. Join us and become part of a team of 50 quality assurance experts and work together to pioneer access for patients. 

Aseptics Ljubljana manufacturing unit provides advanced pharmaceutical products to patients around the world. We are increasingly focusing on biosimilars, which require exceptional quality of processes and procedures, and above all, high professionalism, dedication and commitment of all employees in the unit.

We are looking for a QA Operations Specialist – Microbiology to manage the quality of processes, products and equipment in the Aseptics Ljubljana manufacturing unit.

By joining our company, you will be able to:

• Become familiar with the principles of aseptic production and the procedures for manufacturing sterile products.
• Learn how to establish appropriate aseptic work, based on smoke studies.
• Learn how to establish controls of environmental conditions by establishing cleaning and disinfection processes of premises.
• Become familiar with the importance of monitoring of results of microbiological sampling and results physical parameters of the premises, and learn how to establish appropriate actions based on the results of trends.

Your responsibilities include, but not limited to:

In our multidisciplinary working environment, you will have a dynamic and interesting career with the following job roles and responsibilities:

• Developing internal quality systems in compliance with pharmaceutical legislation, good pharmaceutical practices and Lek/Sandoz quality guidelines.
• Introducing and ensuring standards for effective cleaning, disinfection of premises of different cleanliness classes, and standards for monitoring environmental conditions.
• Review annual environmental condition sampling results and establish appropriate action. 
• Ensuring training/certification of operators in accordance with global guidelines.
• Review and approve documentation of aseptic process simulation.
• Participation in the supervision of the aseptic operations (oversight).
• Working with regular production on:
  - Continuous quality assurance of regular processes and products for the market.  
  - Ensuring quality standards for cleaning, disinfection, monitoring of environmental conditions, and certification of operators. 
  - Establishment of process optimization, recording of smoke studies, cleaning validation of rooms, and control of activities related to room conversions.
  - Deviation investigations in production, or deviations related to environmental monitoring, validation of aseptic process and certification of personnel.
• You will be involved in the transfer of new products into regular production.

Essential Requirements:

• A university degree in a relevant science (microbiology, biology, biotechnology, pharmacy, chemistry, chemical engineering, chemical technology and other life sciences).
• Active knowledge of English and Slovene.
• Work experience in production, development, and quality.
• The desire for new skills, personal development, teamwork and cooperation.

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 temporary contract position with a 6-month probationary period.

You are kindly invited to submit your application in Slovene and/or English language, including your CV, by 31.01.2025.

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

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Skills Desired