Offer Description
Job responsibilites
- Develop, establish, and manage production systems in compliance with Slovenian, European and international legislation (EMA, FDA, ICH, Convention on Pharmaceutical Inspection);
- Prepare, review, and maintain GMP documentation;
- Ensure compliance with current good practices (GxP) and data integrity standards;
- Contribute to the preparation of R&D project proposals;
- Prepare and support for regulatory inspections;
- Participate in deviation investigations and coordinate corrective and preventive actions (CAPA), including follow-up;
- Train and supervise the work of technical staff, facilitate knowledge transfer within the team;
- Contribute to scientific dissemination (reports, presentations, publications, and outreach activities);
- Communicate with external regulatory bodies;
- Maintain continuous professional development;
- Perform additional duties as assigned in line with agreed objectives and performance indicators.
What we expect
Expected Qualifications: PhD; life sciences
Alternative qualifications: PhD in pharmaceutical, biotechnology, biological, chemical, microbiological or other relevant life sciences
Work experience: 4 years. Preferably work experience in production, bioprocess developmnet, sterile process development, quality assurance/quality control, or other professional quality experience.
What we offer
- Duration of employment: Fixed term for the duration of the project, until 31.8.2029
- Probationary period: 4 months
- Working time: 40 hours/week
More info: [contact details available in the full listing]
(dr. Darja Marolt Presen)
Requirements
- Research Field: All
- Education Level: PhD or equivalent
- Languages: ENGLISH
- Level: Good
