Production Documentation Specialist

4 settimane fa


Pisa, Toscana, Italia Takeda Pharmaceutical A tempo pieno

About the Role:

In the realm of production, effective management of documentation is crucial for ensuring compliance and excellence in production standards. As a subject-matter expert, overseeing production changes and conducting related risk assessments is a key responsibility. Moreover, leading projects that enhance production processes and continuous improvement initiatives are essential.

Key Responsibilities:

  • Complete Electrical Manufacturing Batch Record (MES), Equipment Specification (ESP) and related procedures revision, approval, issuance and related SOPs, according to GDDP rules and cGMP compliance.
  • Implement training of Production documentation of its ownership.
  • Be part of the execution of the Change Control as SME for production and support those through risk assessment (quality risk management).
  • Collaborate with regulatory authorities' audits.

Requirements:

  • A degree in Chemistry, Pharmaceutical Technologies, Biology, Biotechnology, or related engineering fields.
  • Experience in pharmaceutical industry, especially in aseptic production.
  • Proficiency in GMP regulations, sterile manufacturing, RABS, and Isolators.
  • Critical thinking, problem-solving, and application of scientific methods.
  • A team player able to collaborate across dynamic departments.
  • Digital and innovation orientation, familiarity with IT applications like Word, Excel, PowerPoint, and Trackwise System.

About Takeda:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. 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.



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