Brief Description:
1. This role is part of the Technical Services Department within the global Manufacturing, Science and Technology Group (MS&T). The role will provide technical support to the manufacturing areas within Villa Guardia Gentium site and also the wider Jazz network as required.
2. The role will provide technical support including production troubleshooting and process optimisation activities, support technology transfer activities.
3. The role will support scale up activities and investigations through small-scale lab/pilot equipment studies.
4. The role will support analytical activities within the technical service group in Villa Guardia as part of the technical support to the processes.
Essential Functions/Responsibilities
5. Planning and execution of experiments at lab or pilot scale to support scale up activities, technology transfer or process investigations.
6. Contribute to the lab housekeeping and equipment qualification and calibration.
7. Delivery of all activities in a timing manner and ensure project delivery on time.
8. Perform analytical test to support investigation/troubleshooting and process improvement activities.
9. Responsible for generation of documentation required for the laboratory activities protocols, SOP and reports.
10. Supporting investigations/ troubleshooting into quality, safety, and downtime issues in manufacturing areas, using RCA tools as appropriate.
11. Supporting technology transfer activities transitioning processes internally (Pharm Dev into Jazz commercial facility, or between commercial facilities)
12. Contribute to continuous improvement and process optimisation initiatives.
13. Strong understanding of Environmental, Health & Safety Requirements
14. Strong understanding of Quality System Requirements
15. Follow Environmental, Health and Safety procedures in compliance with the principle of the company Policy; apply the relevant guidance and indications of the Integrated Management System.
16. Attend education and training courses in the Integrated Management System, GMP Quality, Procedures, Instructions, manuals and Operational Protocols.
17. Perform all work activities, in compliance with the safety directives, as required by Legislative Decree 81/08.
18. Ensure compliance with all applicable Laws, Codes, corporate standards and Procedures related to her/his area of relevance/responsibility, included the legislative decree 231/2001 and requirements of the Jazz Pharmaceuticals Code of Conduct.
19. Strictly observance and knowledge of Jazz Pharmacovigilance’s Policy
Required Knowledge, Skills, and Abilities
20. A minimum of 3/5 years’ experience working in a pharmaceutical production or development role
21. Experience on analytical using GC, HPLC, biological assays and al.
22. Excellent computer literacy
23. Excellent communication skills in English, including written, presentational and technical writing
24. Experience in working in cross functional teams (internally and externally). Develops and maintains positive working relationships with others.
Required/Preferred Education and Licenses
25. PhD or Master in Life Sciences or equivalent through relevant experience.