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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, which includes: thorough review, approval, issuance, and maintenance of documentation in accordance with GDDP regulations and cGMP standards.
conducting training on production documentation (SOPs, MBRs, JA, etc.)
ensuring effective training outcomes.
managing logistics for manufacturing and visual inspection processes.
reviewing production documentation for GDP compliance.
managing data for trending analysis.
Oversee Production Deviation management, including investigations and CAPA.
Identify and address gaps in manufacturing/visual inspection processes; ensure optimization initiatives on the shop floor.
Collaborate in audit preparations and execution.
Manage personnel involved in Production documentation, logistics, Deviation management, and optimization efforts on the shop floor, as well as the identification and resolution of manufacturing and visual inspection gaps.
Receive assignments in the form of objectives and establish goals to meet those objectives; provide guidance to team members to achieve these goals in line with established policies, and monitor team progress.
Responsible for security measures.
ACCOUNTABILITIES: Ensure critical review, approval, issuance, and maintenance of Production documentation (Master Batch Records, SOPs, forms, logbooks, visual aids) in compliance with GDDP and cGMP standards.
Ensure effective training execution on Production documentation ownership/departmental 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 purposes.
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 rectify gaps in manufacturing/visual inspection processes; ensure identification and execution of optimization initiatives 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 the manufacturing of sterile products utilizing RABS and Isolators.
Proficient in English and familiar with key IT applications (Word, Excel, PowerPoint).
Previous experience with Trackwise System is advantageous.
Enthusiasm for 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 assessment.
Strong teamwork capabilities, results-oriented mindset, and effective problem-solving skills.
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 promotes stimulating careers, encourages innovation, and strives for excellence in all endeavors.
We cultivate an inclusive, collaborative workplace where our teams are united by a steadfast commitment to delivering Better Health and a Brighter Future to people 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