:
1. Evaluate manufacturing process documents and equipment cleaning procedures for validation purposes
2. Develop protocols and conduct process validation for product manufacturing and aseptic filling (Media fill)
3. Perform cleaning validation of cleaning procedures and ensure periodic cleaning verification
4. Manage validation protocols for cleaning, process, and Media Fill
5. Collaborate with other departments to define protocol contents and actions to be carried out
6. Validate manufacturing processes, cleaning procedures, and APS/Media Fill
7. Support the drafting and approval of documents for new product transfer and validation
8. Handle deviations related to validation activities
9. Ensure accurate execution of validation activities and detailed analysis of results
10. Draft validation reports and ensure proper archiving of all documentation
11. Provide quality support for new product transfer and process qualification
12. Actively participate in the design, construction, and implementation of new processes or manufacturing departments
Requirements:
13. Bachelor's Degree or equivalent in a scientific/pharmaceutical area
14. 2 years of previous related experience in the pharmaceutical sector
15. Knowledge of pharmaceutical techniques, production, and aseptic filling processes
16. Experience in risk management and client service/project management
17. Proficiency in Microsoft Office software
18. Fluent in English with advanced written and oral communication skills