Validation Specialist

Job Title: QC Validation Expert

Location: Rieti, Italy

Job Type: Full-time

About the Role:

We are seeking a highly skilled QC Validation Expert to join our team at Takeda Pharmaceutical. As a key member of our Quality Assurance department, you will be responsible for ensuring the validation of computer systems and analytical instruments, ensuring data integrity and adherence to regulatory standards.

Key Responsibilities:

• Validation Documentation: Develop and implement validation documentation, including validation plans, system design and configuration, periodic reviews, and operational activities in alignment with the Computer System Validation (CSV) and Analytical Instrument Qualification lifecycle process.

• Regulatory Compliance: Ensure adherence to data integrity standards, and procedures for computer-related analytical laboratory instruments, in compliance with 21 CFR Part 11, EU Annex 11, and GAMP 5.

• Leadership and Collaboration: Provide validation leadership for GXP laboratory analytical instrument/computerized systems and apply risk-based methodology to validation/qualification effort.

• Issue Resolution: Serve as the liaison between QC department, IT and Quality functions, providing timely and effective response and follow-through in issue resolution during installation and qualification activities.

Requirements:

• Education: Master's degree in Science (Chemistry, Pharmaceutical Chemistry or Biology/Biotechnology and engineering).

• Experience: Three years of experience in CSV.

• Skills: 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.

• Personal Qualities: Problem-solving attitude, ability to work a flexible schedule and adapt efficiently to program changes, 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 is transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. We are committed 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.