Quality Assurance Lead

2 settimane fa

Ospedaletto, Italia Takeda Pharmaceutical A tempo pieno

**_ 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.**:

- **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.**:
**Locations**:
ITA - Pisa

**Worker Type**:
Employee

**Worker Sub-Type**:
Regular

**Time Type**:
Full time

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