Site Validation Representative

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Job Description

Job Title: Site Validation Representative

Location: Pisa

As the Site Validation Representative, you will drive continuous improvement and standardization for Global Validation activities related to C&Q. You will be responsible for equipment, facilities utilities and lab equipment (non-bench top) validation as well as validation of sterilization and related validation maintenance. You will also collaborate with/Support the Validation and Calibration Specialist for processes related to calibration activities and during internal/external audit.

Accountabilities:

•           Schedule, plan and manage validation projects including: new facility planning and construction, equipment selections, acquisition, installation and use; facility/system/process improvements, modifications and additions

•           Participate in divisional and corporate C&Q projects

•           Assure coaching and define specific training requirements of the C&Q discipline

•           Responsible for assuring development of team members through internal and external training

•           Develop and administer budgets, schedules, and performance requirements

•           Coordinate activities of personnel in other departments and contractors as well as providing day to day guidance to the Validation staff of the C&Q discipline

•           Participate in audits of other facilities and assists other facilities in their validation efforts as senior SME.

•           Use Kneat Power

•           Quality Management Software (Trackwise, Veeva - Bloom platform)

•           Support as SME (either for C&Q and Calibration disciplines) the Quality Assurance during internal or external Audit presenting Validation Documents

Qualifications:

•           Degree in Engineering, Chemistry, Life Science, or other job-related discipline + At least 7 years of previous experience in this role or equivalent within pharmaceutical, biotechnology, or related industry, familiar with Quality Management and GxP Regulations;

•           Technical English (written and spoken)

•           Analytical skills with systematic approaches to problem solving

•           Familiar with Quality Management and GxP Regulations

•           Proficiency in the following software:

Microsoft Office (Excel and Word)

Validation Programs ( Kneat System)

Instruments (GLIMS; MoDA; Labware)

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.

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