Computer System Validation Technician

hace 2 semanas

Madrid, España Takeda Pharmaceutical A tiempo completo

JOB TITLE**:Computer System Validation Technician**

LOCATION**:Tres Cantos - Spain**

ABOUT THE ROLE:
**_ OBJECTIVES/PURPOSE _**

Based at our Cell Therapy plant in Madrid, CSV Technician will be responsible to lead and manage site CSV validation activities:

- Manage / Execute the CSV projects that are assigned according to the needs of Takeda Madrid Cell Therapy Technology Center, with the aim of achieving the highest degree of Compliance, and at the same time achieving the required efficiency and quality objectives,
- Prepare, review and / or deliver a qualification documentation of IT Infrastructures and Validation of computerized systems that responds to the needs of each project, that complies with the applicable GxP regulations.
- Follow the guidelines set by the management, ensuring compliance with the company's Quality, Environment and Health and Safety policies..

**_ ACCOUNTABILITIES_**
- Manage / Execute the projects assigned by the Line Manager and the Head of the Engineering Department.
- Develop / Review the commissioning and validation documentation of a project (C&Q Plan, Commissioning Protocols, VMP, URS, RA, DQ, IQ, OQ, PQ, Traceability Matrix, etc.)..
- Manage and organize external contractors and validation activities related to them.
- Preparation and review of qualification protocols and reports of equipment, facilities and utilities with GMP impact, and execution of Validation/Qualification activities, including but not limited to (URS / RA / VP / DQ / FAT / SAT / IQ / OQ / PQ).
- Management of Change Control, Deviations, Incidents, CAPA actions
- Carrying out risk analysis, both to establish priorities in the validation and in the development of the validation tests
- Development of general policies and procedures for management, use, changes and deviation management, Corrective and Preventive Actions, etc. of computerized systems in regulated environments.
- Knowledge of qualification of equipment, facilities and services will be valued

HOW YOU WILL CONTRIBUTE:
FUNCTIONAL:

- Analytical skills with systematic approaches to problem solving. Must be able to break down complex problems and tasks into activities capable of being performed by personnel.
- Able to handle multiple task/priorities and the ability to work under specific time constraints are required.

TECHNICAL:

- Experience with protocol development and execution, deviation identification and resolution, and summary/final report authoring. Experience performing statistical analysis of validation test results.
- Sound industry knowledge and proficiency working in a project environment.
- Proficient in MS Office suite
- Fluent Spanish and English (B2), knowledge of other languages will be an asset.

BEHAVIOURAL/INTERPERSONAL:

- Communicate effectively at all levels in verbal and written form, including technical / business writing.
- Ability to work autonomously with little to no supervision.
- Flexibility is important and responsibilities may change, or other duties may arise for this position.
- Education and experience_
- Minimum experience of 3 years as technician for validation of computerized systems in the pharmaceutical industry or similar experience.
- Teamwork, Effective communication & Ability to interact, Adaptation to change, Commitment to the organization, Orientation to Achievement & Results, Planning and Organization, Decision making, Integrity, Excellence in Execution & Diligence
- Travel requirements:_
- Open to travel punctually

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.

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.

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**:
Madrid, Spain

**Worker Type**:
Employee

**Worker Sub-Type**:
Regular

**Time Type**:
Full time

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