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I further affirm that all information I submit in my employment application is accurate to the best of my knowledge.Job OverviewPosition 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.
conduct 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.
manage data for trending analysis.
Oversee Production Deviation management, including investigations and CAPA implementation.
Identify and address gaps in manufacturing/visual inspection processes; ensure optimization on the shop floor.
Collaborate in audit processes.
Supervise personnel involved in Production documentation, logistics, Deviation management, and optimization efforts on the shop floor, while identifying and resolving gaps in manufacturing and visual inspection.
Receive assignments in the form of objectives and establish goals to meet those objectives; provide guidance to team members to achieve goals in line with established policies, while reviewing and monitoring team objectives.
Responsible for security management.
ACCOUNTABILITIES: Ensure critical review, approval, issuance, and maintenance of Production documentation (Master Batch Records, SOPs, forms, logbooks, visual aids) in accordance with GDDP standards and cGMP regulations.
Ensure effective training execution on Production documentation ownership/department responsibilities.
Ensure logistics for manufacturing and visual inspection (preparation and distribution of MBRs and VRs, creation of sampling labels), review production documentation for GDP compliance, and manage data for trending analysis.
Lead investigations related to the manufacturing/visual inspection department, utilizing appropriate tools (e.g., DMAIC); ensure identification and execution of related CAPAs when necessary.
Collaborate with regulatory authorities during audits.
Identify and address gaps in manufacturing/visual inspection processes; ensure optimization initiatives are executed on the shop floor.
WHAT YOU BRING TO TAKEDA Degree in scientific disciplines (Chemistry & Pharmaceutical Technologies, Biology, Biotechnology, Chemistry).
Minimum of 5 years of experience in pharmaceutical companies with extensive knowledge of aseptic production processes.
In-depth understanding of GMP regulations and sterile product manufacturing with RABS and Isolators.
Proficient in English and familiar with key IT applications (Word, Excel, PowerPoint).
Previous experience with Trackwise System is preferred.
Interest in and familiarity with the digitalization of systems/processes.
Strong interpersonal and communication skills, with the ability to influence others.
Capacity to make independent decisions based on data and risk assessments.
Strong team collaboration skills, results-oriented mindset, and effective problem-solving abilities.
More about us:At Takeda, we are dedicated to transforming patient care through the development of innovative specialty pharmaceuticals and exemplary patient support programs.
Takeda is a patient-focused organization that inspires and empowers individuals to grow through impactful work.Recognized as a Global Top Employer, Takeda offers rewarding career opportunities, encourages innovation, and strives for excellence in all endeavors.
We promote an inclusive and collaborative workplace, where our teams are united by a steadfast commitment to delivering Better Health and a Brighter Future to individuals worldwide.Empowering our workforce to excel:Takeda is 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 or characteristics, marital status, or any other characteristic protected by law.LocationsITA - PisaWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
