Manufacturing Deviation and GMP Documentation Specialist

1 mese 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 oversee the management of all activities related to GMP production documentation. This includes critical review, approval, issuance, and maintenance of documentation in accordance with GDDP rules and cGMP compliance standards.


Key Responsibilities:

  • Guarantee production documentation critical revision, approval, issuance, and maintenance according to GDDP rules and cGMP compliance.
  • Execute training on production documentation, ensuring strong training efficacy.
  • Guarantee logistic activities for manufacturing and visual inspection, including preparation and distribution of MBRs and VRs.
  • Collaborate with regulatory authorities' audits and identify gaps in manufacturing/visual inspection to fix those.
  • Guarantee identification and 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 and familiarity with 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 inspires and empowers employees 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.


What We Offer:

  • A diverse and inclusive work environment.
  • A global company with a rich history and a strong commitment to innovation.
  • A competitive salary and benefits package.
  • Opportunities for career growth and professional development.
  • A collaborative and dynamic work environment.

Takeda is an equal opportunities employer and welcomes applications from diverse candidates.


Location: Pisa, Italy


Worker Type: Employee


Worker Sub-Type: Regular


Time Type: Full time


Language: English


Original Language Code: en



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