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You affirm that all details submitted in your application are accurate to the best of your knowledge.Position OverviewJob Title: Manufacturing Deviation and GMP Documentation LeadLocation: PisaOBJECTIVES/PURPOSE: Ensure comprehensive management of all activities associated with GMP production documentation, which includes: meticulous review, approval, issuance, and maintenance of documentation in accordance with GDDP standards and cGMP regulations.
conducting training on production documentation (SOPs, MBRs, JA, etc.)
while ensuring effective training outcomes.
overseeing logistical operations for manufacturing and visual inspection.
reviewing production documentation for GDP compliance.
managing data for trending analysis.
overseeing Production Deviation management, including investigations and CAPA implementation.
identifying and addressing gaps in manufacturing and visual inspection processes; ensuring optimization initiatives on the shop floor.
collaborating in audit preparations and execution.
supervising personnel involved in production documentation, logistical activities, deviation management, and optimization efforts.
receiving assignments in the form of objectives and setting goals to achieve them; providing guidance to team members to meet established objectives.
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 within the respective department.
Oversee logistical operations for manufacturing and visual inspection, including preparation and distribution of MBRs and VRs, and creation of sampling labels, while ensuring GDP compliance in documentation.
Lead investigations related to manufacturing and visual inspection, utilizing appropriate methodologies (e.g., DMAIC) and ensuring identification and execution of relevant CAPAs.
Collaborate with regulatory authorities during audits.
Identify and rectify gaps in manufacturing and visual inspection processes, ensuring optimization on the shop floor.QUALIFICATIONS: Degree in scientific fields (Chemistry, Pharmaceutical Technologies, Biology, Biotechnology).
Minimum of 5 years of experience in pharmaceutical environments 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 essential IT applications (Word, Excel, PowerPoint); prior experience with Trackwise System is advantageous.
Enthusiastic about the digitalization of systems and processes.
Strong interpersonal and communication skills, with the ability to influence others.
Capacity to make independent decisions based on data and risk assessment.
Excellent teamwork abilities, results-oriented mindset, and strong problem-solving skills.About Takeda: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-centric organization that encourages personal and professional growth through impactful work.Recognized as a Global Top Employer, Takeda promotes stimulating career opportunities, fosters innovation, and strives for excellence in all endeavors.
We cultivate an inclusive and collaborative work environment, where our teams are united by a shared commitment to delivering Better Health and a Brighter Future for individuals worldwide.Our commitment to diversity:Takeda is proud to uphold its commitment to creating 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
