Production Documentation Specialist

3 settimane fa


Pisa, Toscana, Italia Takeda A tempo pieno

Purpose and Scope

The Production Documentation Specialist will oversee the management of all activities related to production documentation ownership, ensuring cGMP compliance and the execution of related training. This role will be responsible for executing documentation revision, issuance, and maintenance according to GDDP rules.

Key Responsibilities

  • Execute effective training of Production documentation of its ownership.
  • Execute Change Control activities with impacts on production and support those through adequate and strong risk assessment.
  • Collaborate with regulatory authorities' audits.
  • Execute production activities as support to process, cleaning validation and technical operation activities with impact on Production process/equipment.

Requirements

  • Degree in scientific disciplines (Chemistry & Pharmaceutical Technologies, Biology, Biotechnology, Chemistry).
  • 3-5 years of experience in pharmaceutical companies.
  • Deep knowledge of aseptic production process and GMP regulations.
  • Organizational, analysis and prioritization ability.
  • Communication skills, ability to influence other.
  • Flexibility, ability to rapid adaption to changes.
  • Ability to take/propose decisions based on risk evaluation.
  • Strong team-working ability and results orientation.
  • Problem solving ability.
  • Good knowledge of English and of the main IT applications (Word, Excel, Power Point).

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.



  • 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...


  • Pisa, Toscana, Italia Takeda A tempo pieno

    About the Role:In the realm of production, management of documentation is crucial. This encompasses the creation, revision, and issuance of electronic Manufacturing Batch Records and Equipment Specifications, all in strict adherence to GDDP and cGMP standards.As a subject-matter expert, overseeing production changes and conducting related risk assessments is...


  • Pisa, Toscana, Italia Takeda A tempo pieno

    About the Role:In the realm of pharmaceutical production, proper documentation management is crucial for maintaining quality and compliance. As a subject-matter expert, you will oversee production changes, conduct risk assessments, and lead projects to enhance production processes and continuous improvement initiatives.Your Key Responsibilities:Complete and...


  • Pisa, Toscana, Italia Takeda A tempo pieno

    DescriptionJob Title: GMP Documentation SpecialistLocation: PisaEnsure GMP compliance through effective management of production documentation, including critical revision, approval, issuance, and maintenance.Develop and execute training programs on production documentation, focusing on strong training efficacy.Manage logistics for manufacturing and visual...

  • Production Specialist

    3 settimane fa


    Pisa, Toscana, Italia Takeda A tempo pieno

    About the Role:Takeda is seeking a highly skilled Production Specialist to oversee production documentation, manage change control, and ensure compliance with GMP regulations. The ideal candidate will have experience in aseptic production and a strong understanding of sterile manufacturing processes.Key Responsibilities:Develop, revise, and approve...

  • Production Specialist

    2 settimane fa


    Pisa, Toscana, Italia Takeda A tempo pieno

    About the Role:In the pharmaceutical industry, the effective management of documentation is crucial for production processes. As a subject-matter expert, the Production Specialist will oversee the creation, revision, and issuance of electronic Manufacturing Batch Records and Equipment Specifications, adhering to GDDP and cGMP standards.Main...


  • Pisa, Toscana, Italia Takeda A tempo pieno

    About the Role:As the Manufacturing Deviation and GMP Documentation Specialist, 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...


  • Pisa, Toscana, Italia Takeda A tempo pieno

    About the Role:Takeda is seeking a highly skilled Manufacturing Deviation and GMP Documentation Lead to join our team in Pisa, Italy.Job Summary:The Manufacturing Deviation and GMP Documentation Lead will be responsible for managing all activities related to GMP production documentation, including critical revision, approval, issuance, and maintenance...


  • Pisa, Toscana, Italia Takeda Pharmaceutical A tempo pieno

    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.Key Responsibilities:Guarantee production...


  • Pisa, Toscana, Italia Takeda A tempo pieno

    Job Description:Purpose: We are seeking a highly skilled Manufacturing Deviation and GMP Documentation Specialist to join our team at Takeda. The successful candidate will be responsible for ensuring the management of all activities related to GMP production documentation, including critical revision, approval, issuance, and maintenance according to GDDP...


  • Pisa, Toscana, Italia Takeda Pharmaceutical A tempo pieno

    Job Title: Manufacturing Deviation and GMP Documentation LeadWe are seeking a highly skilled Manufacturing Deviation and GMP Documentation Lead to join our team at Takeda Pharmaceutical. As a key member of our quality assurance team, you will be responsible for ensuring the management of all activities related to GMP production documentation, including...


  • 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...


  • Pisa, Toscana, Italia Takeda Pharmaceutical A tempo pieno

    About the Role:As the GMP Compliance 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.Key Responsibilities:Guarantee production documentation critical...


  • Pisa, Toscana, Italia Takeda Pharmaceutical A tempo pieno

    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...


  • Pisa, Toscana, Italia Takeda A tempo pieno

    Job Title: Manufacturing Deviation and GMP Documentation LeadLocation: PisaAs a key member of our team, you will be responsible for managing all activities related to GMP production documentation, including critical revision, approval, issuance, and maintenance according to GDDP rules and cGMP compliance. You will also be responsible for executing training...


  • Pisa, Toscana, Italia Takeda A tempo pieno

    Job DescriptionAbout 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.Key Responsibilities:Guarantee production documentation critical revision approval, issuance, maintenance (Master Batch Records, SOPs, forms, logbooks, visual...


  • Pisa, Toscana, Italia Takeda A tempo pieno

    Job Title: Manufacturing Deviation and GMP Documentation LeadLocation: PisaKey Responsibilities:Ensure management of all activities related to GMP production documentation, including critical revision, approval, issuance, and maintenance according to GDDP rules and cGMP compliance.Execute training on production documentation, ensuring strong training...


  • Pisa, Toscana, Italia Takeda A tempo pieno

    Job Title: Manufacturing Deviation and GMP Documentation LeadLocation: PisaAs a key member of our team, you will be responsible for ensuring the management of all activities related to GMP production documentation, including critical revision, approval, issuance, and maintenance according to GDDP rules and cGMP compliance.Key Responsibilities:Manage the...


  • Pisa, Toscana, Italia Takeda A tempo pieno

    We are seeking a highly skilled Pharmaceutical Compliance Specialist to join our team in Pisa, Italy.About the role:Guarantee compliance with GDDP rules and cGMP regulations for production documentation and manufacturing processes.Develop and implement effective training programs for production staff to ensure strong understanding of production documentation...


  • Pisa, Toscana, Italia Palmer Johnson A tempo pieno

    Production Coordinator Job DescriptionAbout the Role:Schedule production using Microsoft Project, ensuring seamless execution and quality control. Coordinate internal resources to deliver projects on time, within scope, and budget. Lead technical team meetings to monitor progress, address challenges, and promote teamwork.Requirements:Excellent communication...