Head of Quality Pisa - Takeda Pharmaceutical

Takeda Pharmaceutical

Azienda verificata

Pisa, Italia

3 settimane fa

Inviato da:

Piero Bianchi

Reclutatore di talenti per beBee

Descrizione

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JOB TITLE:
Head of Quality Pisa_

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LOCATION:
PISA_

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ABOUT THE ROLE:
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_OBIETTIVI/SCOPO _

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To guarantee management of Pisa Quality Department in alignment with current regulations, Takeda internal requirements

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HOW YOU WILL CONTRIBUTE:
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_ RESPONSABILITA' _

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Guarantee that each lot of final product is manufactured, controlled and checked for compliance by quality release functions, according to current GMPs and license requirements. To guarantee to track within adequate quality documentation the activities for the production, control and internal release for each lot manufactured.

To review/approve the final CoC for the product;

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Communicate immediately to local MOH and to Plant responsible any not conformity noticed for the product already distributed in the market

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Actively cooperate during the regulatory inspections and to guarantee to put in place the related requested adequate actions

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Supervise the Hygiene program of the personnel for which is responsible and to guarantee the respect of the related GMP, Ch
2, for hygiene program

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Guarantee the management of reference/retention samples of each lot manufactured and the execution of stability studies on final product according to cGMP requirements

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Communicate to local MOH each significant change applied to the plant

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Responsible to maintain the documentation, and available in case of request by authority

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_ WHAT YOU BRING TO TAKEDA__:_**:

_ DIMENSIONI E ASPETTI _

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Esperienza tecnico/funzionale

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Analytical skills and problem solving

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Knowledge of regulations for manufacture and release of biological products

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English communication

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Leadership

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Global leadership skills

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Good Capacity to lead the changes across the quality organization

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Processi ed Autonomia decisionale

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Has authority to do not release the lot in case of problem on quality and safety of product

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Must be able to deal with ambiguity and take decision under stressful conditions

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Establish priorities for activities

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Interazione

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Internal with site Head Manufacturing global and local quality and regulatory affairs as well as with local regulators

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Innovazione

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Should be current knowledge of state of the art of processes and systems related to production as well as control of the products

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Complessità

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Must be able to work in controlled/classified environments requiring special gowning.

Required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body

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Deals with plasma products; intermediates and finished products; transfer of products between sites/countries

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FORMAZIONE E COMPETENZE:
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Advanced degree in science; qualified person education desirable

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Minimum 5 years in quality, aseptic manufacturing (preferably with strong focus on fill/finish operations) or related field in the pharmaceutical industry, preferably plasma industry

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Demonstrate the Takeda leadership behavior be positive, accountable and be an excellent manager of self and others

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MORE ABOUT US

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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

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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

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EMPOWERING OUR PEOPLE TO SHINE

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_ 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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Locations

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ITA - Pisa

Worker Type

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Employee

Worker Sub-Type

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Regular

Time Type

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Full time