Qc Validation Specialist Lazio

Qc Validation Specialist
Roma
Lazio, Lazio

POSITION**:QC VALIDATION SPECIALIST**:

LOCATION: RIETI**:

ABOUT THE ROLE**:

- **Ensure on-time analytical method validation/method transfer/comparability studies activities supporting QC functions.

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Support method performance monitoring process.

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**HOW YOU WILL CONTRIBUTE**:

- **Writes, reviews, and approves GMP compliant method validation documents.

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Support QC instrument qualification, implementation, and lifecycle in accordance with approved procedures and compendial requirements.

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Timely manages and sustains method performance monitoring activities (assay control assignment/critical material qualification)**:

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Learn and perform required laboratory techniques using novel and established protocols as well Standard Operation Procedures.

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Knowledge of main analytical and statistical tools.

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**WHAT YOU BRING TO TAKEDA**:

- **Laboratory technical background and knowledge of chromatography techniques will be preferred.

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Knowledge of requirements related to quality control.

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English knowledge and communication skills (verbal and written, including technical writing).

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Ability to work a flexible schedule and adapt efficiently to program changes.

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Problem solving attitude.

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Knowledge of analytical chemistry, method validation and instrument qualification.

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Must be able to work in controlled GMP area and be aware of requirements and risks associated with laboratory environment, classified area and low temperature cold room.

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Handling of hazardous and biologic materials.

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- **Education / experience**:

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Master's degree (5 years) in science (Chemistry, Pharmaceutical Chemistry or Biology/ Biotechnology).

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L'appartenenza alle Categorie Protette, ai sensi degli articoli 1 e 18 della legge 68 del '99, sarà considerata condizione preferenziale.

**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.

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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**:**_

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. _**:

**Locations**:

ITA - Rieti

**Worker Type**:

Employee

**Worker Sub-Type**:

Fixed Term (Fixed Term)

**Time Type**:

Full time