QA Operations Specialist – Microbiology
Lek, a Sandoz company · Ig
Opis delovnega mesta
About the role
Join the Bio Injectable products unit in Brnik to ensure the highest quality of microbiological processes, products and equipment for a new manufacturing and quality control site. You will gain hands‑on experience with aseptic production, environmental monitoring and cleaning procedures in a GMP‑driven environment.
Key responsibilities
- Develop, maintain and improve quality systems in line with pharmaceutical regulations, GMP and internal Sandoz guidelines.
- Establish and control cleaning, disinfection and environmental monitoring programs for cleanrooms of various cleanliness classes.
- Analyze monitoring data, review annual trends and implement corrective and preventive actions.
- Support validation activities for aseptic filling and other aseptic manufacturing processes.
- Lead investigations of deviations related to environmental conditions, operator qualifications and aseptic processes.
Required profile
- University degree in microbiology, biology, biotechnology, pharmacy, chemistry, chemical engineering or related life science.
- Active knowledge of English and Slovenian.
- Work experience in production, development or quality within the pharmaceutical sector.
- Motivation for personal development, teamwork and continuous learning.
Required skills
- Microbiology expertise.
- Good Manufacturing Practices (GMP) knowledge.
- Aseptic filling and validation procedures.
- Environmental monitoring and data analysis.
- Cleaning and disinfection protocol implementation.
What we offer
- Permanent contract with a 6‑month probation period and a competitive annual gross salary (€30,960 – €46,440).
- Annual bonus, vacation allowance, Christmas bonus and share allocation.
- Fully funded supplementary pension plan (5.844% of gross salary).
- Shift allowances, collective life and accident insurance, and a hybrid work environment.
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Lek, a Sandoz company
Ig
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