Job Title: Manufacturing Deviation and GMP Documentation LeadLocation: PisaOBJECTIVES/PURPOSE: Oversee all activities related to GMP production documentation, ensuring compliance with established guidelines.
Conduct critical reviews, approvals, and maintenance of documentation in accordance with GDDP regulations and cGMP standards.
Facilitate training on production documentation (SOPs, MBRs, JA, etc.)
to ensure effective knowledge transfer.
Manage logistics for manufacturing and visual inspection processes.
Review production documentation to ensure adherence to GDP compliance.
Manage data for trending analysis.
Supervise Production Deviation management, including investigations and CAPA implementation.
Identify and address gaps in manufacturing and visual inspection processes, ensuring continuous improvement on the shop floor.
Collaborate with audit teams for compliance assessments.
Lead a team responsible for production documentation, logistics, deviation management, and process optimization.ACCOUNTABILITIES: Ensure critical revision, approval, and maintenance of production documentation (Master Batch Records, SOPs, forms, logbooks, visual aids) in line with GDDP and cGMP requirements.
Guarantee effective training execution on production documentation within the department.
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) and ensuring CAPAs are identified and executed as necessary.
Collaborate with regulatory authorities during audits.
Identify and rectify gaps in manufacturing and visual inspection processes, ensuring optimization is executed on the shop floor.WHAT YOU BRING TO TAKEDA: A degree in scientific disciplines (Chemistry & Pharmaceutical Technologies, Biology, Biotechnology, Chemistry).
A minimum of 5 years of experience in the pharmaceutical industry with a strong understanding of aseptic production processes.
In-depth knowledge of GMP regulations and sterile product manufacturing using RABS and Isolators.
Proficiency in English and familiarity with key IT applications (Word, Excel, PowerPoint).
Experience with Trackwise System is advantageous.
A keen interest in the digitalization of systems and processes.
Strong interpersonal and communication skills, with the ability to influence stakeholders.
Capability to make independent decisions based on data and risk assessments.
A collaborative mindset with a focus on results and problem-solving skills.More about us:At Takeda, we are dedicated to transforming patient care through innovative specialty pharmaceuticals and exceptional patient support programs.
As a patient-centric organization, we empower our employees to thrive through impactful work.Recognized as a Global Top Employer, Takeda promotes stimulating career opportunities, 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 globally.We are committed to fostering a diverse workforce and providing equal employment opportunities to all employees and applicants, regardless of 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.
