Quality Assurance Specialist

2 giorni fa

Milano, Lombardia, Italia Takeda Pharmaceutical A tempo pieno

About the Role: We are seeking a highly motivated and experienced Quality Assurance Specialist to join our dynamic team in Rieti. As a key member of our Quality Assurance team, you will be responsible for ensuring that our manufacturing processes and systems meet the highest standards of quality and regulatory compliance.



Main Responsibilities:



  • Protocol Review and Approval: Review and approve validation protocols, reports, deviation reports, specifications, risk assessments, validation plans, and related documentation.
  • Quality Function Assessment: Perform quality function assessments for calibration in accordance with company procedures.
  • Equipment and System Validation: Verify and maintain the validation status of equipment, systems, cleaning processes, and production processes.
  • Project Collaboration: Actively participate in projects as a Quality Validation representative, promoting diversity of thought and innovation.
  • Validation Activity Monitoring: Monitor validation activities and analyze performance indicators.
  • Document Management: Manage and track documents and periodic requalification/revision activities for manufacturing systems.


Requirements:



  • Education: Bachelor's degree in a scientific field (Chemistry, Biotechnology, Pharmacy, or related fields).
  • Pharmaceutical Experience: Experience in the pharmaceutical industry, focusing on process and system validation.
  • Normative Knowledge: In-depth knowledge of GMP regulations.
  • Organizational, Analytical, and Problem-Solving Skills: Excellent organizational, analytical, and problem-solving skills with a quality- and innovation-oriented mindset.
  • Language and IT Skills: Good command of English and proficiency in IT tools.
  • Appreciation for Diversity: We welcome candidates with diverse experiences and backgrounds that can enrich our company culture.


About Takeda: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. We are a patient-focused company that inspires and empowers our employees 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, united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.



Empowering Our People: Takeda is proud of its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information, or any other characteristic protected by law.


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