Manufacturing Deviation and GMP Documentation Lead

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Job Description Job Title: Manufacturing Deviation and GMP Documentation Lead Location : Pisa OBJECTIVES/PURPOSE: Assure management of all activities related to all GMP production documentation; that includes: critical revision, approval, issuance, maintenance of documentation according to GDDP rules, cGMP compliance. execution of training on production documentation (SO Ps, MB Rs, JA, etc…) by assuring strong training efficacy. logistic activities for manufacturing and visual inspection. revision of production documentation per GDP compliance. data management for trending purpose.
Assure management of Production Deviation, that includes investigation and CAPA.
Assure management of identification of gaps in manufacturing/visual inspection to fix those; assure identification/execution of the optimization on the shop floor.
Assure collaboration for audit execution.
Management of direct people involved in Production documentation, Logistic activities, Deviation management, optimization on the shop floor, identification/resolution of gaps in manufacturing and visual inspection.
Receives assignment in the form of objectives and establishes goals to meet objectives; provide guidance to subordinates to achieve goals in accordance with established policies, review/monitor goals of the team.
Person in charge for security.
ACCOUNTABILITIES: .
Guarantee Production documentation critical revision approval, issuance, maintenance ( Master Batch Records, SO Ps, 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 MB Rs and V Rs, creation of sampling labels), revision of production documentation per GDP compliance, data management for trending purpose.
Guarantee execution/leading of investigations related to manufacturing/visual inspection department, applying appropriate tools (i. e. : DMAIC); guarantee identification/execution of related CAP As 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).
At least 5 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.
Locations ITA - Pisa Worker Type Employee Worker Sub- Type Regular Time Type Full time