Description
Job Title: Manufacturing Change Control & GMP Documentation
Location: Rieti
The role involves overseeing GMP documentation management and revision, ensuring thorough and accurate processing. It includes executing training programs to maintain high levels of competency, managing change requests and conducting risk assessments to mitigate potential issues. Additionally, the position supports various projects and plays a key role in preparing for both internal and external audits.
1. Issue and review of GMP Documentation
2. Support the maintenance of the GMP documentation archive related to own department, including the responsibility to collect and destroy documents
3. Project management and change request opening and management
4. Support MES project implementation
5. Carrying out activities relating to GMP compliance in the field and operational problem solving
6. Identification of improvement opportunities to align GMP compliance in production
7. Writing/Executing/reviewing RA
8. Performance of staff training regarding specific operating procedures, in compliance with the principles of Lean Manufacturing
9. Support in preparing and carrying out internal and external audits
10. BS in life sciences or related field
11. Manufacturing experience of at least 1 year
12. Good science knowledge and main principles of pharmaceutical manufacturing equipment
13. Knowledge of cGMP with respect to the production process
14. Quality risk management
15. GMP documentation experience
16. Experience supporting MES implementation
17. Organizational and personnel management skills
18. Relationship and communication skills
19. Good knowledge of the English language
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Empowering our people to shine:
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.
Locations
ITA - Rieti
Worker Type
Employee
Worker Sub-Type
Fixed Term (Fixed Term)
Time Type
Full time