GMP Compliance Specialist

1 settimana fa

Pisa, Toscana, Italia Takeda Pharmaceutical A tempo pieno
About the Role

We are seeking a highly skilled Manufacturing Deviation and GMP Documentation Lead to join our team at Takeda Pharmaceutical. As a key member of our manufacturing team, you will be responsible for overseeing the management of all activities related to GMP production documentation.

Key Responsibilities
  • 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 to manufacturing/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.
Requirements
  • 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.
About Takeda

Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. We are certified as a Global Top Employer and offer stimulating careers, encourage innovation, and strive 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.

We are proud in our 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.

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