Qc Validation Specialist Lazio

Qc Validation Specialist
Roma
Lazio, Lazio

Job Title**:QC Validation Specialist

Location**:Rieti

**_ About the role:_

**_ PURPOSE:_**:

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

- Support method performance monitoring process.

**_ HOW YOU WILL CONTRIBUTE:_

**ACCOUNTABILITIES**:

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

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

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

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

- Knowledge of main analytical and statistical tools.

**_ ASPECTS:_

**Technical/functional experience

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

- Knowledge of requirements related to quality control.

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

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

- Problem solving attitude.

- Knowledge of analytical chemistry, method validation and instrument qualification.

- 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.

- Handling of harzardous and biologic materials.

**_ WHAT YOU BRING TO TAKEDA_**_:_

**_ COMPETENCES:_

Education / experience

- Master's degree (5 years) in Science

(Chemistry, Pharmaceutical Chemistry or Biology/ Biotechnology).

**Locations**:

ITA - Rieti

**Worker Type**:

Employee

**Worker Sub-Type**:

Fixed Term (Fixed Term)

**Time Type**:

Full time