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Quality Assurance Specialist

2 mesi fa


Roma, Lazio, Italia Takeda A tempo pieno
About the Role

We are seeking a highly skilled Quality Assurance Specialist to join our team at Takeda. As a key member of our Quality Assurance department, you will be responsible for ensuring the accuracy and reliability of our computer systems and analytical instruments.

Key Responsibilities
  • Develop and implement validation documentation and activities to ensure compliance with regulatory requirements.
  • Collaborate with cross-functional teams to ensure data integrity and adherence to quality standards.
  • Provide leadership and guidance on validation and qualification efforts, applying risk-based methodologies to ensure compliance with 21 CFR Part 11, EU Annex 11, and GAMP 5.
  • Serve as a liaison between Quality Assurance, IT, and Quality functions to ensure effective issue resolution and communication.
Requirements
  • Master's degree in Science (Chemistry, Pharmaceutical Chemistry, Biology/Biotechnology, or Engineering).
  • Three years of experience in Computer System Validation (CSV).
  • Proven knowledge of quality control and regulatory requirements.
  • Excellent communication and problem-solving skills.
  • Ability to work in a fast-paced environment and adapt to changing priorities.
About Takeda

Takeda is a global pharmaceutical company committed to 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 to grow through life-changing work. We foster an inclusive, collaborative workplace where our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.