Quality Systems

hace 4 días

Madrid, España Takeda Pharmaceutical A tiempo completo

Quality Systems & Compliance Analyst

LOCATION**:Tres Cantos - Spain**

ABOUT THE ROLE:
**Objectives of position**: Implement the Quality Systems at Takeda Madrid aligned with local, international and corporate compliance requirements.

**_ ACCOUNTABILITIES_**
- Participate in audits and inspections, both internal and external and related CAPAs
- Participate in developing programs to ensure the correct implementation of the Quality Systems as well as compliance with GMP requirements.
- Carry out the internal control responsibilities set forth for the procedures of your job.
- Implement, manage and control quality systems (LEADS, EQMS, TW)
- Approve and manage controlled documents such as SOPs & Forms
- Maintain the local Quality Management System updated and harmonized with the Global Quality Management System
- Manage suppliers and service providers to assure their compliance with local, international and corporate requirements.
- Manage training program, develop and execute the annual training program of the site, working in collaboration with the different stakeholders of the site
- Review and approve protocols and reports of qualification, validation of equipment, cleaning validation, methods, risk analysis, including those related to CSV.
- Manage quality complaints.

**HOW YOU WILL CONTRIBUTE**:
EDUCATION AND EXPERIENCE
- Bachelor of Natural Sciences, preferably in Pharmacy, Biology or Chemistry;
- Minimum of 3 years of experience in the environment of the pharmaceutical industry within the Quality areas (Quality Assurance, Systems or Compliance)

FUNCTIONAL
- Experience working with systems (document management, quality events, ERP and others
- Experience with document management, Change control, CAPA, GMP training.

TECHNICAL
- Knowledge of qualification and validation, including CSV
- Fluent in English

BEHAVIOURAL/INTERPERSONAL
- Experience working with complex organizations and the ability to work in all functions and with all levels of the organization where the owner may not have direct authority.
- Leadership skills

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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