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I confirm that all information submitted is accurate to the best of my knowledge.Position OverviewJob Title: Manufacturing Deviation and GMP Documentation LeadLocation: PisaOBJECTIVES/PURPOSE: Oversee all activities related to GMP production documentation, including: thorough review, approval, issuance, and maintenance of documentation in compliance with GDDP standards and cGMP regulations.
Facilitate training on production documentation (SOPs, MBRs, JA, etc.)
ensuring effective training outcomes.
Manage logistics for manufacturing and visual inspection processes.
Review production documentation for GDP compliance.
Conduct data management for trending analysis.
Supervise Production Deviation management, including investigations and CAPA implementation.
Identify and address gaps in manufacturing and visual inspection processes; execute optimization strategies on the shop floor.
Collaborate on audit preparations and execution.
Lead and manage team members involved in production documentation, logistics, deviation management, and optimization efforts.
Set objectives and goals for the team, providing guidance to achieve targets in alignment with established policies.
Responsible for security measures.ACCOUNTABILITIES: Ensure critical review, approval, issuance, and maintenance of production documentation (Master Batch Records, SOPs, forms, logbooks, visual aids) in accordance with GDDP and cGMP standards.
Guarantee effective training execution on production documentation ownership and responsibilities.
Manage logistics for manufacturing and visual inspection, including preparation and distribution of MBRs and VRs, and creation of sampling labels.
Lead investigations related to manufacturing and visual inspection, utilizing appropriate methodologies (e.g., DMAIC); ensure identification and execution of CAPAs as necessary.
Collaborate with regulatory authorities during audits.
Identify and rectify gaps in manufacturing and visual inspection processes; execute optimization initiatives on the shop floor.QUALIFICATIONS: Degree in scientific fields (Chemistry, Pharmaceutical Technologies, Biology, Biotechnology).
Minimum of 5 years of experience in pharmaceutical settings with a comprehensive understanding of aseptic production processes.
Extensive knowledge of GMP regulations and sterile product manufacturing using RABS and Isolators.
Proficient in English and familiar with key IT applications (Word, Excel, PowerPoint); experience with Trackwise System is a plus.
Enthusiastic about digitalization of systems and processes.
Strong interpersonal and communication skills, with the ability to influence others.
Capable of making independent decisions based on data and risk assessments.
Excellent teamwork abilities, results-oriented mindset, and strong problem-solving skills.About Takeda:At Takeda, we are dedicated to transforming patient care through innovative specialty pharmaceuticals and exceptional patient support programs.
As a patient-focused organization, we empower our employees to thrive through impactful work.Recognized as a Global Top Employer, Takeda promotes stimulating careers, encourages innovation, and strives for excellence in all endeavors.
We cultivate an inclusive and collaborative workplace, where our teams are united by a shared commitment to deliver Better Health and a Brighter Future to individuals worldwide.We are committed to fostering a diverse workforce and providing equal employment opportunities to all employees and applicants, without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information, marital status, or any other characteristic protected by law.LocationsITA - PisaWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
