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Job Description QC Validation Expert Rieti OBJECTIVES/PURPOSE: Primarily responsible for computer systems and analytical instruments validation documentation.
Ensure the planning, development, and implementation of validation documentation.
Ensuring adherence to data integrity standards, and procedures for computer related analytical laboratory instruments.
ACCOUNTABILITIES: Primarily responsible for ensuring computer systems and analytical instruments validation documentation, inclusive of 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.
Ensure the planning, development, and implementation of validation documentation and activities.
Ensuring adherence to data integrity standards, and procedures for computer related analytical laboratory instruments.
Provide validation leadership for GXP laboratory analytical instrument / computerized systems and applies risk-based methodology to validation/qualification effort in compliance with 21 CFR Part 11, EU Annex 11, and GAMP 5.
Serves as the liaison between QC department, IT and Quality functions, provides timely and effective response and follow-through in issue resolution during installation and qualification activities.
WHAT YOU BRING TO TAKEDA: Master's degree in Science (Chemistry, Pharmaceutical Chemistry or Biology/ Biotechnology and engineering).
Three years of experiences in 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).
More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs.
Takeda is a patient-focused company that will inspire and empower you to grow 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, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Empowering our people to shine: Takeda is proud in 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.
Locations ITA - Rieti Worker Type Employee Worker Sub-Type Regular Time Type Full time