QA Operations Expert (Quality Assurance)
Lek, a Sandoz company · Ig
Job description
About the role
Sandoz is establishing a new site for aseptic bio‑injectable production in Brnik and seeks a QA Operations Expert to ensure product quality and patient safety. You will work closely with manufacturing and analytical teams, applying regulatory knowledge and internal standards to support product release and continuous improvement.
Key responsibilities
- Review and evaluate manufacturing and analytical documentation for compliance.
- Assess batch suitability for release according to marketing authorisation requirements.
- Release medicinal products in line with EU, FDA, local legislation and contractual obligations.
- Participate in deviation management, change controls and performance indicator monitoring.
- Contribute to the development and optimisation of the internal Quality Management System under GMP.
- Support regulatory inspections and ensure processes meet the highest quality standards.
- Perform additional tasks defined by annual objectives and performance indicators.
Required profile
- University degree in Pharmacy or a related pharmaceutical discipline.
- Minimum three years of Quality Assurance experience within Slovenian medicinal product regulations.
- Experience in pharmaceutical development or manufacturing, especially aseptic processes, is highly desirable.
- Fluent in English and proficient in Slovenian.
- Strong motivation, independent work style, proactive mindset and excellent communication skills.
Required skills
- Microsoft Office applications.
What we offer
- Permanent contract with a six‑month probation period.
- Opportunity to work at Sandoz sites in Ljubljana and Brnik.
- Engagement in a dynamic, science‑driven environment focused on global healthcare.
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Published 4 weeks ago
Expires 1 month from now
21 views · 0 interested
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Lek, a Sandoz company
Ig