Validation Specialist - CATEGORIE PROTETTEMultiple Locations
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
- 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.
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Job Title: Validation Specialist
Location: Rieti - Italy
ABOUT THE ROLE:
Coordinate and Support Validation activities and plan execution.
Primary tasks include development of protocols, coordination of validation activities, qualification/validation execution, preparing final reports and assembly of final validation packages, project plans drafting.
Understand systems features and functionalities and related criticalities and develop and execute validation documents as appropriate in compliance with responsible instructions, main internal and external guidelines and policies, assuring Validation activities plan completion.
Contribute to development, continuous improvement, efficiency and harmonization of business processes, workflows, quality systems and procedural guidance and International standardization
Responsible to stay within agreed timelines and follow applicable guidelines. May support presentation of Validation Documentation during internal or external Audits.
HOW YOU WILL CONTRIBUTE:
Develop documents for Validation activities (, protocols, final report, validation plan, risk assessment, technical document )
Execute and /or coordinate assigned Validations related to C&Q area.
Coordination and Training of personnel of external support companies
Manage deadlines, change control activities /tasks related to the production systems as assigned.
Guarantee communications with Customers and Interfaces for the assigned duties and items
Participate or Lead Risk Assessments
Participate in internal or external audits to present validation
Support Input for Validation during Regulatory Submissions
Assist during FAT and SAT with Engineering and Supplier
Participate at Workshops/Projects for Continuous Improvement and global standardization initiatives and communities within the organization
Support maintenance of document GMP archive including the responsibility for correct consultation, data collection, retrieval and returning of documents and archiving process
Execution and /or coordination of assigned Validations related to C&Q area.
Knowledge of the main quality systems (documentation, audit, change control, training )
Ability to perform Routine Tasks with limited Supervision
Ability to Coordinate resources for some specific task/activity
Ability to perform Routine Tasks with limited Supervision
Ability to represent department in meetings for assigned topics
Be able to manage relationships:
- Internal relationship: Production , Engineering, Quality, QC Quality validation, Manufacturing science
- External relationship: Suppliers for external consultants services, Global validation
Provide Input for Changes, Issues resolution specifically for technical failure analysis on routine/projects processes/systems
May support other sites by sharing know how
May support/lead global initiatives implementation
Definition of validation strategies, identification of the appropriate criteria to be adopted in qualifying and evaluation of the results obtained.
Management of validation documentation.
WHAT YOU BRING TO TAKEDA:
Degree in Engineering, Chemistry, Life Science, or other job-related discipline
At least 3 years of previous experience in this role or equivalent within pharmaceutical, biotechnology, or related industry, familiar with Quality Management and GxP Regulations
Fluent English (written and spoken);
Analytical skills with systematic approaches to problem solving
Familiar with Quality Management and GxP Regulations
Proficiency in Microsoft Office
May require some travel (<5%).
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.
LocationsITA - Rieti
Time TypeFull time
Working at Takeda
InclusionHere, you will feel welcomed, respected, and valued as a vital contributor to our global team.
CollaborationA strong, borderless team, we strive together towards our priorities and inspiring mission.
InnovationBold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
Top WorkplaceRecognized for our culture and way of working, we’re one of only 15 companies to receive Top Global Employer® status for 2023.
Work-LifeOur people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
EmpowermentThrough 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
Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.
Create an exceptional people experience.
Protect our planet.
Data & Digital
Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.
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