Manufacturing Change Control & GMP Documentation, Rieti
Client:
Takeda
Location:
Rieti
Job Category:
Other
Job Opportunities:
-
EU Work Permit Required:
Yes
Job Reference:
0e8d1ac9141f
Job Views:
10
Posted:
16.06.2025
Expiry Date:
31.07.2025
Job Description:
Description
Job Title: Manufacturing Change Control & GMP Documentation
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.
Responsibilities:

Issue and review GMP documentation
Support maintenance of GMP documentation archive, including document collection and destruction
Manage project change requests
Ensure GMP compliance and resolve operational issues
Identify opportunities for GMP process improvements
Write, execute, and review risk assessments
Train staff on operating procedures, following Lean Manufacturing principles
Assist in internal and external audit preparations

Qualifications:

Bachelor's degree in life sciences or related field
At least 1 year of manufacturing experience
Strong knowledge of pharmaceutical manufacturing and GMP principles
Experience with quality risk management and MES implementation
Organizational and communication skills
Proficiency in English

About Takeda:
Takeda is committed to transforming patient care through innovative pharmaceuticals and support programs. Recognized as a Global Top Employer, we foster an inclusive and collaborative environment dedicated to excellence and better health outcomes worldwide.
Additional Notes:
If you are not a passport holder of the country for the vacancy, a work permit may be required. Please apply via the 'Apply now' button. Do not provide bank or payment details during application.
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