Validation Expert

Job Title: Quality Validation Analyst

Location:

We are seeking a highly motivated and experienced Quality Validation Analyst to join our diverse and dynamic team. The successful candidate will be responsible for ensuring that production processes and systems meet the highest standards of quality and regulatory requirements, contributing to the continuous improvement of our processes in an inclusive and collaborative environment.

Main Responsibilities:

• Review and approval of validation protocols, reports, deviation reports, specifications, risk assessments, validation plans, and related documentation.
• Execution of the Quality function regarding calibration assessments, in accordance with company procedures.
• Verification and maintenance of the validation status of equipment, systems, cleaning and production processes.
• Active collaboration in projects as a representative of the Quality Validation department, promoting diversity of thought and innovation.
• Monitoring of validation activities and analysis of performance indicators data.
• Management and tracking of documents and periodic requalification/revision activities for manufacturing systems.

Requirements:

• Bachelor's degree in scientific disciplines (Chemistry, Biotechnology, Pharmacy, or related fields).
• Experience in the pharmaceutical industry, with a focus on process and system validation.
• Thorough knowledge of GMP regulations.
• Excellent organizational, analytical, and problem-solving skills, with a quality-oriented and innovative mindset.
• Good command of the English language and computer tools.
• We are open to candidates with diverse experiences and backgrounds that can enrich our company culture.

Takeda is a patient-focused company that inspires and empowers you to grow through life-changing work. We are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs.

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.

Takeda is proud of 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.