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Job Description

Sarà considerato requisito preferenziale l'appartenenza alle categorie protette (legge n. 68/99)

Job Title: Quality System Analyst

Location: Pisa

The Quality System Analyst will report to the Quality System Supervisor and will be responsible for ensuring maintaining the Change Control process, ensuring compliance with relevant regulations and standards, and driving efficiency and effectiveness in the system. The QS Analyst will be also responsible for the execution of the on board training and annual refresh training developed by the Global training team and delivered to the personnel of the plant, as well as managing Key Performance Indicators (KPIs) related to change control and quality system performance.

Key Responsibilities

• Develop and maintain the Change Control system, including policies, procedures, and documentation.
• Collaborate with cross-functional teams to identify and assess changes, ensuring they are properly evaluated and documented.
• Review change requests, ensuring they meet the necessary criteria and are aligned with regulatory requirements.
• Monitor and track changes throughout the entire lifecycle, ensuring timely completion and appropriate closure.
• Identify areas for improvement in the Change Control system and implement process enhancements to drive efficiency and effectiveness.
• Provide training and support to employees on Change Control processes and procedures.
• Collaborate with internal and external stakeholders to address any issues or concerns related to the Change Control system.
• Stay updated with industry best practices and regulatory changes related to Change Control.
• Tracking and analyzing KPI metrics of change controls and quality system performance.
• Guarantee that KPIs are provided on time according to Global requirements

Qualifications

• Bachelor's degree in a relevant field (e.g., Phamraceutical Chemistry, Pharmacy, Biology)

• Proven experience in quality management systems, with a focus on Change Control (3-5 years of experience required)

• Knowledge of quality management systems, GMP, and regulatory requirements.
• Proven experience within a pharmaceutical regulated industry.
• Good communication skills in English.

Technical Skills And Competences Required

• Proficient in using quality management software and tools such as Trackwise.
• Excellent analytical and problem-solving skills
• Attention to detail and ability to work with complex information.

• Strong communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams.
• Ability to work independently and collaboratively in a team environment.
• Strong organizational and time management skills, with the ability to prioritize tasks and meet deadlines.

• Flexible, adaptable to new and innovative ideas.
• Strong training and facilitation skills, with the ability to effectively deliver training sessions and support employees in learning new processes

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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