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QA Operations Expert – upravljanje kakovosti
SandozQA Operations Expert ensuring GMP compliance for Sandoz combination-product assembly and packaging. Supporting validations, audits, CAPA, and new biosimilar manufacturing in Slovenia.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in quality management and compliance within pharmaceutical regulations, including GMP requirements. Proficient in managing quality systems, documentation reviews, and supporting product transfers in regulated environments.
Highest-signal resume keywords
Quality ManagementGMP ComplianceManufacturing Documentation ReviewRegulatory Affairs CollaborationPharmaceutical Regulations Knowledge
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Quality Systems DevelopmentBatch Manufacturing Records ReviewDeviation ManagementCAPA ImplementationProcess ValidationEquipment QualificationRisk AssessmentCombination Product ManufacturingMedical Device KnowledgeRegulatory Inspection Participation
Soft Skills
TeamworkCollaborationContinuous LearningProfessional Development
Industry Keywords
Pharmaceutical IndustryMedical Device IndustryEU MDRFDA Combination ProductsCombination ProductsAutoinjectorsNeedle Safety Systems
Tech Stack
Tools & technologiesAssembly
About the role
Key responsibilities & impact- Ensure quality management of combination product assembly processes, packaging operations, and compliance with GMP and regulatory requirements
- Develop and maintain quality systems in accordance with pharmaceutical regulations, GMP requirements, and Sandoz internal guidelines
- Provide quality support for combination product assembly and finished product packaging operations
- Review and approve manufacturing documentation, validation documentation, and batch manufacturing records
- Manage deviations, complaints, changes, risk assessments, and CAPA implementation
- Support equipment qualification, process validation, and introduction of new products and technologies
- Perform batch documentation reviews
- Participate in internal and external audits and regulatory inspections
- Collaborate with Manufacturing, Engineering, Validation, Quality Control, Regulatory Affairs, and other technical functions
- Support transfer of new products into commercial manufacturing
Requirements
What you’ll need- University degree in Pharmacy, Chemistry, Biotechnology, Mechanical Engineering, Medical Technology, or another relevant scientific or technical discipline
- Proficiency in Slovenian and English
- At least 3 years of experience in manufacturing, development, or quality within the pharmaceutical, medical device, or another regulated industry
- Experience in manufacturing combination products, medical devices, autoinjectors, or needle safety systems is an advantage
- Knowledge of European and US regulations for medical devices and combination products, including EU MDR and FDA Combination Products, is an advantage
- Strong desire for continuous learning, professional development, teamwork, and collaboration
- Submit application in English and Slovene, including a CV
Benefits
Comp & perks- Annual bonus (STI): percentage of annual salary
- Vacation allowance: in 2025 it was €2,430.99 net
- Christmas bonus: in 2025 it was €2,100 gross
- OurShare: employees of Lek d.d. receive Sandoz AG shares annually
- Voluntary Additional Pension Scheme: company fully covers 5.844% of gross salary
- Collective life and accident insurance (24/7 coverage)
- Hybrid work environment offering flexibility and remote work possibilities, if applicable for the position