Quality Assurance Specialist

6 giorni fa


Milano, Lombardia, Italia Takeda A tempo pieno
Job Description

Job Title: Quality Assurance Specialist

Location: Rieti, Italy

Job Type: Full-time

About Us: Takeda is a global pharmaceutical company dedicated to transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs.

Job Summary: We are seeking a highly skilled Quality Assurance Specialist to join our team in Rieti, Italy. As a Quality Assurance Specialist, you will be responsible for ensuring the planning, development, and implementation of validation documentation for computer systems and analytical instruments.

Key Responsibilities:

  • Ensure adherence to data integrity standards and procedures for computer-related analytical laboratory instruments.
  • Provide validation leadership for GXP laboratory analytical instrument/computerized systems and apply risk-based methodology to validation/qualification efforts in compliance with 21 CFR Part 11, EU Annex 11, and GAMP 5.
  • Serve as a liaison between the QC department, IT, and Quality functions, providing timely and effective responses and follow-through in issue resolution during installation and qualification activities.

Requirements:

  • Master's degree in Science (Chemistry, Pharmaceutical Chemistry, or Biology/Biotechnology and engineering).
  • Three years of experience in Computer Systems Validation (CSV).
  • Proven knowledge of requirements related to quality control and 21 CFR Part 11, EU Annex 11, and GAMP 5.
  • Ability to effectively communicate and multitask.
  • Prioritize, plan, and actively participate in multi-tasking validation AIQ activities within agreed timelines.
  • Ability to work a flexible schedule and adapt efficiently to program changes.
  • Problem-solving attitude.
  • Good Microsoft Office applications (Excel, PowerPoint, WORD).
  • English knowledge and communication skills (verbal and written, including technical writing).

About Takeda: Takeda is a patient-focused company that inspires and empowers its employees to grow through life-changing work. We are certified as a Global Top Employer and offer stimulating careers, encourage innovation, and strive 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.

Equal Employment Opportunity: 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 protected by law.



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