Sterile Process Specialist At Novartis

Sterile Process Specialist At Novartis

Sterile Process Specialist At Novartis

Job Description

1. Participate in reallocation of products into different work centers.
2. Participate in root cause analysis in case of deviations, problem solving as well as process improvement.
3. Coach personnel through the Lean manufacturing
4. Solicit ideas for improvements
5. Transfer of technical knowledge to team members
6. Give support to technical training if needed
7. Support improvement for line efficiencies
8. Products\process recipe managemeNovartisnt for equipment
9. Participate in product transfers and new introductions
10. Issuing the manufacturing documents (e.g. filled batch record, deviation reports, logbooks etc..) within a process unit to ensure continuous operational running.
11. Execute and review SAP related activities.
12. Encourage, evaluate, assist and implement the continuous improvement ideas to achieve productivity improvement within the process unit.
13. Handling process complaints\ deviations to ensure timely and accurate investiga-tion and feedback.
14. Support execution of firmed finite schedule according to lean principles to achieve agreed upon KPIs.
15. Assure compliance to cGMP within PU by monitoring personnel behaviours.
16. Responsible for day to day implementation of cGMP, DI, HSE & Novartis guidelines
within the operational units.
17. Assumes the role of HSE coordinator within the PU
18. Execution of all HSE related tasks within the PU
19. Applying HSE technical knowledge and skills to ensure basic level of compliance
and performance within departments
20. Anticipate potential risk exposure through applying basic HSE knowledge within
21. . Enhance HSE awareness within function
22. Support in implementation of HSE & BC objectives and programs
23. Frequent presence within the workplace to guarantee compliance and discuss
HSE issues with team
24. Ensure that unsafe behavior, usage of dangerous equipment within the operations
are reported and investigated
25. Ensure that team members follow procedures and working practices to fulfill
business needs, GMP, DI & HSE requisites
26. Coordinate HSE training plans with all concerned individuals
27. Issue/ coordinate HSE annual training reports and justify training gaps from preset
28. Assure compliance to HSE regulations within PU through monitoring of personnel
behaviors ad detect gaps for any additional training topics to be added or retraining
29. Encourage and assist data integrity speak up culture.
30. Assure on time execution of all corrective and preventive actions related to audit
findings, deviations and quality site risk assessment and report progress on a
monthly basis to PU Head.
Key Performance Indicators (Indicate how per

Commitment to Diversity & Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum requirements

From 1 to 3 years experience

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