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Job Description

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

Job Title: Quality on the shop floor

Location: Pisa – Italy

The Quality on the shop floor will ensure that the production processes for the manufacturing of sterile products are executed following cGMP/Annex 1 regulations and in adherence to the internal and global procedures. The candidate must have a strong microbiological background and have gained experience in relevant investigations and data analysis, with robust aptitude for problem solving.

Key Responsibilities of Quality on the shop floor are the following:

• Promote the application of good manufacturing practices in terms of aseptic behavior and ensure training and oversight of activities related to aseptic process.
• Ensure compliance with regulatory requirements; develop and maintain standard operating procedures (SOPs) for sterile processes.
• Ensuring that aseptic processing aligns with international standards by providing technical oversight.
• Support the definition and implementation of the appropriate contamination control strategies (CCS) and promote the continuous improvement in aseptic technique culture/behavior.
• Conduct risk assessments and develop mitigation strategies to minimize the risk of contamination, identifying potential sources of contamination and developing strategies to mitigate the risk.
• Collaborate with cross-functional teams to ensure that all products are manufactured in compliance with sterility requirements.
• Provide training to employees on sterilization processes, GMP/Annex 1 requirements and procedures. ensuring that all employees are trained in the appropriate processes and procedures.
• Participate in audits and inspections to ensure compliance with regulatory requirements.
• Provide technical support and Subject Matter Expert inputs for manufacturing-related process improvements, change control, deviation investigation, and CAPA implementation.
• Coordinate the process to guarantee the site inspection readiness; participate to site self-assessments.
• Identify and implement, in close collaboration and partnership with the production/warehouse/engineering departments, actions to improve and simplify activities, always in full compliance with GMP requirements, regulatory and corporate requirements.
• Critically evaluate environmental monitoring data, perform a trend data analysis.
• Collaborate at global level to harmonize the practices/procedures/processes between the various sites across the network.

Qualifications:

• Bachelor's degree in a relevant field such as microbiology, biology, or biochemistry
• Minimum of 3+ years of experience in the same role or quality assurance Dept. in a pharmaceutical manufacturing environment.
• Knowledge of current regulatory requirements for Aseptic manufacturing that use RABs and isolator technologies and cGMP /Annex 1
• Experience in investigations and data analysis, with aptitude for problem solving
• Knowledge of Aseptic manufacturing process and related   microbiological aspect
• Knowledge of MODA, Labware, Trackwise, JDE (ERP system) systems
• Communication and interpersonal skills to collaborate with cross-functional teams and provide training to employees.
• Be able to work in a dynamic environment to ensure that all products are manufactured in compliance with sterility requirements.
• Ability to work under pressure and to organize and prioritize multiple tasks.

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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