Manufacturing Deviation and GMP Documentation Lead
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Job Title: Manufacturing Deviation and GMP Documentation Lead
Location: Pisa
ABOUT THE ROLE:
As the Manufacturing Deviation and GMP Documentation Lead, You will oversee the management of all activities related to GMP production documentation. This includes the critical review, approval, issuance, and maintenance of documentation in accordance with GDDP rules and cGMP compliance standards. Additionally, you will be responsible for executing training on production documentation, such as SOPs, MBRs, and JAs, ensuring that the training is highly effective.
HOW YOU WILL CONTRIBUTE: .
Guarantee Production documentation critical revision approval, issuance, maintenance (Master Batch Records, SOPs, forms, logbooks, visual aid) according to GDDP rules and cGMP compliance.
Guarantee execution of training on Production documentation of its ownership/department by assuring strong training efficacy.
Guarantee logistic activities for manufacturing and visual inspection (preparation and distribution of MBRs and VRs, creation of sampling labels), revision of production documentation per GDP compliance, data management for trending purpose.
Guarantee execution/leading of investigations related tomanufacturing/visual inspection department, applying appropriate tools (i.e.: DMAIC); guarantee identification/execution of related CAPAs when applicable.
Collaborate with regulatory authorities’ audits.
Guarantee identification of gaps in manufacturing/visual inspection to fix those; guarantee identification/execution of optimization on the shop floor.
WHAT YOU BRING TO TAKEDA
Degree in scientific disciplines (Chemistry & Pharmaceutical Technologies, Biology, Biotechnology, Chemistry).
Relevant years of experience in pharmaceutical companies and deep knowledge of aseptic production process.
Deep knowledge of GMP regulations and manufacturing of sterile products with RABS and Isolators.
Good knowledge of English and of the main IT applications (Word, Excel, Power Point). Previous use of Trackwise System.
Familiarity and appetite for digitalization of systems/process.
Strong relationship and communication skills, ability to influence other.
Ability to take independent decisions based on data evaluation and risk evaluation.
Strong team-working ability and results orientation as well as strong problem solving skills
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Empowering our people to shine:
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment 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.
