QA Operations Specialist – Microbiology (d/f/m)
Lek, a Sandoz company · Ig
Opis delovnega mesta
About the role
Sandoz is looking for a QA Operations Specialist – Microbiology (d/f/m) for its Bio Injectable products unit in Brnik, Slovenia. The role manages the quality of processes, products and equipment for the new manufacturing and quality control site, covering environmental monitoring, aseptic filling validation and operator certification.
Key responsibilities
- Develop, maintain and improve quality systems in line with pharmaceutical regulations, GMP and Sandoz/Lek quality guidelines.
- Set standards for cleaning and disinfection of cleanrooms and environmental monitoring programmes, and analyse monitoring data and trends.
- Implement corrective and preventive actions based on environmental monitoring results.
- Ensure operator training and certification according to global standards.
- Review, approve and support validation of aseptic filling and other aseptic processes, and oversee the transfer of new products to commercial manufacturing.
- Work with manufacturing teams on process optimisation, smoke studies and facility modifications.
- Lead investigations of deviations and quality events related to environmental conditions, operator qualifications and aseptic processes.
Required profile
- University degree in a relevant science (microbiology, biology, biotechnology, pharmacy, chemistry, chemical engineering or other life sciences).
- Active knowledge of English and Slovenian.
- Work experience in production, development and quality.
- Desire for new skills, personal development, teamwork and cooperation.
What we offer
- Permanent contract with a 6-month probation period, 40 hours per week, annual gross salary of 30,960–46,440 EUR depending on experience.
- Annual performance bonus, vacation allowance and Christmas bonus.
- OurShare: annual entitlement to Sandoz AG shares.
- Voluntary additional pension scheme fully covered by the employer.
- Shift, night, weekend and overtime allowances; collective life and accident insurance.
- Hybrid work environment with remote work possibilities where applicable.
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Lek, a Sandoz company
Ig
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