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Informazioni offerta

Sede

Pisa

Settore funzionale

Qualita' e sicurezza

Descrizione

OBJECTIVES/PURPOSE

  • To ensure the release of human albumin lots manufactured at the site according to regulatory / GMP requirements, and Takeda standards.

  • To ensure the environmental control of the manufacturing process areas

  • To execute the role of Qualified Person (QP) for the plant

  • To cover the EHS role of “Preposto” according to the Italian legislation (art.2 comma 1 lettera E, DL8 1/2008)

  • ACCOUNTABILITIES

    To assure that each lot of final product is manufactured, controlled and checked for compliance by quality release functions, according to current GMPs, license requirements and to local SOPs.

    To ensure the adequate quality documentation oversight concerning manufacturing activities (including batch record review), controls and internal release for each lot manufactured in Pisa site; to evaluate and assess the criticality of related events, OOS, and changes, in order to execute the adequate release process according to Takeda and Local SOPs.

    To review/approve the Certificate of Compliance (CoC) for the product.

  • ACCOUNTABILITIES

    To assure that each lot of final product is manufactured, controlled and checked for compliance by quality release functions, according to current GMPs, license requirements and to local SOPs.

    To ensure the adequate quality documentation oversight concerning manufacturing activities (including batch record review), controls and internal release for each lot manufactured in Pisa site; to evaluate and assess the criticality of related events, OOS, and changes, in order to execute the adequate release process according to Takeda and Local SOPs.

    To review/approve the Certificate of Compliance (CoC) for the product.

    To deploy and implement quality system elements and procedures related to CAPA, EUME; EM program; product release, in order to ensure product conformity to the established requirements.

    To ensure Quality review and approval of investigation/ Deviations/CAPA’s.

    To assure initial training and continuous appropriate job training for the recruited quality personnel for the duties assigned to them (quality, Quality operations).

    To assure escalation to Senior Management of critical issues of product, and to assure hold disposition of the lots when applicable.

    To assure the adequate EM plan with Quality Assurance Operational functions for the control of the manufacturing process, and related trend analysis, according to requirement of Takeda& Local SOPs.

    To assure adequate Shop floor activities with Quality Assurance Operational functions, according to requirements of Takeda &Local SOPs.

    To guarantee the execution of periodical process simulation testing, with the Quality Operation functions, according to Takeda/local SOPs.

    To contribute to Quality processes improvements, by applying Continuous Improvements’ initiatives.

    To drive at site level the implementation of the established quality strategies/goals for own quality assurance team; to contribute to establish quality operational budget.

  • DIMENSIONS AND ASPECTS

    Technical/Functional (Line) Expertise (Breadth and depth of knowledge, application and complexity of technical knowledge)

  • Analytical skills and problem solving.

  • Critical thinking skills.

  • Knowledge of regulations concerning the manufacturing and release of biological products.

  • Good English communication (written and verbal).

  • Leadership

  • Creates the working environment that inspires and enable people to move the organization forward.

  • Focuses on the priorities: build structure that reduce unnecessary complexity.

  • Developed leadership skills in managing Quality team.

  • Able to manage and lead the changes across the quality organization

  • Decision-making and Autonomy Has authority to reject the lot in case of safety and product quality issues.

  • Able to take decision under stressful decision.

  • Establish priorities for activities to follow in own organization.

  • Interaction

    Interact with site Manufacturing Manager, Engineering manager, EHS Manager.

  • HR, Pisa-Rieti Quality Head; Rieti Quality functions, Pisa-Rieti IT manager; RA group; Vienna Quality release.

  • Knowledge of Risk Management tools.

  • Digital knowledge in accessing and managing information.

  • GMP requirement Annex 1 for sterile products.

  • Complexity

  • Knowledge of Sterile Manufacturing Process of final product and related control tests.

  • Human Albumin manufacturing sterile process.

  • EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: 

  • Degree in Scientific Area.

  • Minimum 3 years in Quality supervisory role (with past experience in Quality Control environment).

  • Embrace Takeda leadership behavior: positive, accountable, and be an excellent manager of self and others.


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