Compliance Coordinator Lazio

Compliance Coordinator
Roma
Lazio, Lazio

POSITION: COMPLIANCE COORDINATOR**:

**LOCATION: RIETI**:

**ABOUT THE ROLE**:

- **Support the change management process with Regulatory affairs and local authority impact.

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- ** Support Reg CMC dossier and variations issuing and tracking**:

- ** Support self, internal, and authorities GMP inspections**:

**HOW YOU WILL CONTRIBUTE**:

- **Support the preparation of AIFA documentation and communication as per follow up questions or actions for essential and not essential modification to the Manufacturing License.

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- ** Support the drafting of the variations of eCTD Module 3 (Quality) as per company project plans and related CMC changes and MoH questions.

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- ** Support the alignment process of internal documentation to the eCTD and GMP requirements.

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- ** Support regular GMP or Pre-Approval Inspections conducted by internal auditor and/or Authorities**:

- ** Collaborate to Risk Management process for facility changes**:

- ** Collaborate in management of License Information (LI) and Post market Commitments (PMC)**:

**WHAT YOU BRING TO TAKEDA**:

- ** Knowledge of European and US cGMP Regulations and Pharmaceutical Quality System**:

- ** Good written and spoken English**:

- ** Knowledge of DLg 219**:

- ** Microsoft Office tools and Informatics Systems**:

**Desired**: 3-5 years of experience in Pharmaceutical Quality System/Quality Assurance and/or in plasma manufacturing process.

Regulatory Master degree.

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**Leadership & Behaviors**:

- ** Be Positive**:

- ** Be Accountable**:

- ** Be Results Oriented**:

- ** Be team working oriented**:

**Degree in Chemistry / Biochemistry / Biology or equivalent scientific disciplines.

Good written and spoken English language.

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**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**:

Regular

**Time Type**:

Full time