1. Prepares, reviews and approves production, validation, audit reports documents, procedures, and rationales.
2. Evaluates new regulations, changes to existing regulations and regulatory trends; prepares inspections and customer audit responses and reports; performs gap analysis to resolve efficiencies and take appropriate actions.
3. Defines, in collaboration with other partners (Quality Assurance, System Owner…) the requalification strategy of GMP systems and implements it, including maintaining the quality system and complete practical activities.
4. Coordinates execution of activities by external contractors.
5. Performs requalification and revalidation Work Orders, including routine and non-routine operations, and documents in forms and OMX following Good Documentation Practices
6. Participates in the culture of continuous improvement and development of technologies.
7. Identifies training needs and develop training programs.
8. Works in a safe and responsible manner in order to build an injury-free and incident-free workplace.
9. Participates in calibration activities
Requirements
10. Bachelor’s degree in Biotechnology, Quality, Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or a related field.
11. + 10 years experience or Master's degree + 3 years in the engineering field, preferably in the pharmaceutical, or chemical process industry.
12. Functional knowledge of cGMPs and manufacturing operations in FDA regulated facility.
13. Experience in the pharmaceutical industry for qualification & validation is required
14. Experience of multi-cultural work environment
15. Excellent verbal and written communication skills in English and preferably German or another European language
16. Strong understanding of GMP standards and regulatory requirements.
17. Excellent technical writing skills with attention to detail.
18. Proficiency in PC applications, including MS Office.
19. Strong communication and interpersonal skills.
20. Certification in technical writing or quality management.
21. Experience with electronic documentation management systems (, Documentum, TrackWise).
If you are driven and excited to support our mission, we would love to hear from you.