Manufacturing Change Control & GMP Documentation
Rieti, ItalyRieti, Italy| Santa Rufina, Italy
On the Global Manufacturing and Supply (GMS) team at Takeda, you’ll be part of a rapidly transforming industry that’s applying technology and data in new ways. Within our agile, innovative, people-centric organization, your work will matter every day as you use your skills to help us manufacture therapies for patients on our four platforms:
- Small Molecules
- Biologics
- Plasma
- Cell and Gene
As part of the GMS team, you'll have the opportunity to pursue unique experiences and build new skills, and you'll know that the work you do every day makes an impact — on our patients, our people, our planet, and on yourself.
Rieti, Italy| Santa Rufina, Italy
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Job Description
Sarà considerato requisito preferenziale l'appartenenza alle categorie protette (legge n. 68/99)
Job Title:Manufacturing Change Control & GMP Documentation
Location: Rieti
About the role:
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.
How you will contribute:
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
What you bring to Takeda:
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
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 - RietiWorker Type
EmployeeWorker Sub-Type
Fixed Term (Fixed Term)Time Type
Full timeWorking at Takeda
-
Inclusion
Here, you will feel welcomed, respected, and valued as a vital contributor to our global team. -
Collaboration
A strong, borderless team, we strive together towards our priorities and inspiring mission. -
Innovation
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients. -
Top Workplace
Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2024. -
Work-Life
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family. -
Empowerment
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
We're Steadfast In Our Commitment to Four Key Imperatives
Patient
Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.
People
Create an exceptional people experience.
Planet
Protect our planet.
Data & Digital
Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.
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