Validation Specialist - CATEGORIE PROTETTE

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Job Description

Annuncio dedicato alle persone appartenenti alle categorie protette - legge 68/99.

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.

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