Manufacturing Change Control & GMP Documentation
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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.
Issue and review of GMP Documentation
Support the maintenance of the GMP documentation archive related to own department, including the responsibility to collect and destroy documents
Project management and change request opening and management
Support MES project implementation
Carrying out activities relating to GMP compliance in the field and operational problem solving
Identification of improvement opportunities to align GMP compliance in production
Writing/Executing/reviewing RA
Performance of staff training regarding specific operating procedures, in compliance with the principles of Lean Manufacturing
Support in preparing and carrying out internal and external audits
BS in life sciences or related field
Manufacturing experience of at least 1 year
Good science knowledge and main principles of pharmaceutical manufacturing equipment
Knowledge of cGMP with respect to the production process
Quality risk management
GMP documentation experience
Experience supporting MES implementation
Organizational and personnel management skills
Relationship and communication skills
Good knowledge of the English language
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.
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.
