QA Manager (d/f/m) ESO
Novartis
- Kundl, Tirol
- Unbefristet
- Vollzeit
- Acts as Single Point of Contact / SPOC for all quality related activities at assigned external suppliers.
- Supplier qualification: Ensures a valid Quality Agreement in line with the requirements of the Sandoz global template is in place and continuously amended to the business needs.
- Routine monitoring: Assesses quality trends and drives continuous improvement including stability reports and annual product quality reviews.
- Incident management: Manages all quality issues (complaints, deviations, OOX).
- Change controls: Ensures that change requests, either from the external supplier or from Sandoz, are managed appropriately from receipt, through to the implementation and closure.
- Manufacturing process and analytical methods transfers: Ensures QA Oversight during commercial product transfers.
- Bachelor or higher in Biochemistry, Chemistry, Microbiology or anoth-er related science
- Fluent in speaking / writing in English
- Min 5 years of experience in in the pharmaceutical industry. Min 3 years of experience in the manufacturing of sterile pharmaceuticals. Basic knowledge in aseptic/sterile pharmaceutical processes and manufacturing of biologics.
- Min 3 years of experience in operational quality assurance. Advanced knowledge of cGMP requirements for major regulated markets (EU, US). Basic experience with FDA, EMEA and other Health Authorities. Advanced understanding of risk management. Basic understanding of project management.
- Advanced communication and basic negations skills. Basic decision-making ability skills.