Associate Expert Drug Supply (Clinical Manufacturing)
novartis · Mengeš
Opis delovnega mesta
About the role
Novartis Slovenia is looking for an Associate Expert Drug Supply to join its Clinical Manufacturing Operations (Cx MO) team at the Clinical Manufacturing site in Mengeš, Slovenia. The role supports the manufacturing process through environmental monitoring of cleanrooms, product change-over and compliance with regulations, company procedures and GxP requirements. It is a hybrid position (#LI-Hybrid).
Key responsibilities
- Ensure compliance with quality, ethics, health, safety, environment and information security standards, and with GxP regulations.
- Collaborate with internal and external stakeholders, share knowledge, train and coach colleagues and help solve routine and non-routine problems.
- Propose and implement continuous improvement ideas and support internal and external audits.
- Plan, organise, perform and document CMO activities under moderate supervision, including cleanroom and clean utilities sampling, product change-over and material and sample handling.
- Prepare, issue, complete and archive documentation (logs, forms, batch records) and review data prepared by others.
- Carry out, interpret and report results, author and review documents such as cleaning documentation, and keep assigned work areas tidy.
Required profile
- High school degree or equivalent in pharmacy, biotechnology, chemistry, microbiology or a related field.
- At least 1 year of directly related experience in biologics manufacturing.
- Fluent Slovene; technical knowledge of English.
- Permanent employment with a 6-month probation period; applications with a CV in Slovenian and English.
Required skills
- Adequate knowledge of software and computer tools (e.g. Microsoft Office)
- Desirable: knowledge of GxP and the Cx MO environment (cleanrooms, personnel and material flows)
What we offer
- Expected annual base salary range in Slovenia of EUR 22,820 to 42,380, set according to skills, competencies and experience.
- Annual bonus of 12% of annual base salary.
- Holiday allowance (about EUR 2,496 net in 2025).
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novartis
Mengeš
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