Quality Systems and Compliance Analyst
hace 2 semanas
**About the role**:
The Quality Systems and Compliance Analyst will implement the Quality Systems at Takeda Madrid aligned with local, international and corporate compliance requirements.
**How you will contribute**:
- Maintain the local Quality Management System updated and harmonized with the Global Quality Management System, coordinating the action plans to be aligned with the global quality system
- Approve and manage controlled documents such as SOPs & Forms
- Participate in audits and inspections, both internal and external and related CAPAs
- Conduct self-inspections in the site and follow-up the implementation of corrective and preventive actions
- Change control management assuring a correct implementation of the changes, including the lead of the change control committee
- Lead and provide guidance on Quality Risk Assessments
- Provide guidance to the organization about aseptic practices
- Review and approve protocols and reports of qualification, validation of equipment, cleaning validation, methods, risk analysis, including those related to CSV.
- Manage suppliers and service providers to assure their compliance with local, international and corporate requirements.
- Manage quality complaints.
**What you bring to Takeda**:
- Bachelor of Natural Sciences, preferably in Pharmacy, Biology or Chemistry;
- Minimum of 3 years of experience in the environment of the pharmaceutical industry, with a minimum of 3 years in the Quality areas (Quality Assurance, Systems or Compliance)
- Fluent in English
- Experience working with electronic quality management systems (document management, quality events, as Trackwise, others
- Ability on data trends and analysis
- Deep knowledge in GMPs and aseptic practices
- Experience in quality systems management, i.e. QRM, Change control, CAPA, GMP training.
- Experience in managing audits and inspections
- Knowledge of qualification and validation, including CSV
- Flexibility, managing different responsibilities and adaptable to changes
- Manage complexity, working at different levels of the organization leading cross-functional groups in which you may not have direct authority.
- Ensure accountability
- Teamwork abilities
- Lead continuous improvement
- Strategic vision
**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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