Lavori attuali relativi a Manufacturing Deviation and GMP Documentation Specialist - Pisa, Toscana - Takeda Pharmaceutical
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Manufacturing Deviation and GMP Documentation Specialist
2 settimane fa
Pisa, Toscana, Italia Takeda A tempo pienoAbout 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...
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Pisa, Toscana, Italia Takeda Pharmaceutical A tempo pienoJob 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...
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Manufacturing Deviation and GMP Documentation Lead
2 settimane fa
Pisa, Toscana, Italia Takeda A tempo pienoJob 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...
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Manufacturing Deviation and GMP Documentation Lead
4 settimane fa
Pisa, Toscana, Italia Takeda A tempo pienoJob Title: Manufacturing Deviation and GMP Documentation LeadLocation: PisaJob Summary:We are seeking a highly skilled Manufacturing Deviation and GMP Documentation Lead to join our team at Takeda. As a key member of our production team, you will be responsible for ensuring the management of all activities related to GMP production documentation, including...
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Pisa, Toscana, Italia Takeda A tempo pienoJob 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...
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Manufacturing Deviation and GMP Documentation Lead
3 settimane fa
Pisa, Toscana, Italia Takeda A tempo pienoJob Title: Manufacturing Deviation and GMP Documentation LeadLocation: PisaAbout the Role:We are seeking a highly skilled and experienced Manufacturing Deviation and GMP Documentation Lead to join our team at Takeda. As a key member of our production team, you will be responsible for ensuring the management of all activities related to GMP production...
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Pisa, Toscana, Italia Takeda A tempo pienoJob 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...
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Manufacturing Deviation and GMP Documentation Lead
2 settimane fa
Pisa, Toscana, Italia Takeda A tempo pienoJob 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...
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Manufacturing Deviation and GMP Documentation Lead
2 settimane fa
Pisa, Toscana, Italia Takeda Pharmaceutical A tempo pienoAbout 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...
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Manufacturing Deviation and GMP Documentation Lead
4 settimane fa
Pisa, Toscana, Italia Takeda A tempo pienoAbout the Role:We are seeking a highly skilled Manufacturing Deviation and GMP Documentation Lead to join our team at Takeda. As a key member of our production 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...
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Manufacturing Deviation and GMP Documentation Lead
4 settimane fa
Pisa, Toscana, Italia Takeda A tempo pienoAbout the Role:We are seeking a highly skilled Manufacturing Deviation and GMP Documentation Lead to join our team at Takeda. As a key member of our production 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...
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GMP Documentation Specialist
4 giorni fa
Pisa, Toscana, Italia Takeda A tempo pienoDescriptionJob 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...
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GMP Compliance Documentation Specialist
4 giorni fa
Pisa, Toscana, Italia Takeda Pharmaceutical A tempo pienoAbout 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...
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Production Documentation Specialist
3 settimane fa
Pisa, Toscana, Italia Takeda A tempo pienoAbout the Role:Takeda is seeking a highly skilled professional to join our team as a Production Documentation Specialist. In this role, you will be responsible for managing production documentation, including the creation, revision, and issuance of electronic Manufacturing Batch Records and Equipment Specifications. You will also oversee production changes...
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Production Documentation Specialist
4 settimane fa
Pisa, Toscana, Italia Takeda A tempo pienoAbout the Role:Takeda is seeking a highly skilled professional to join our team as a Production Documentation Specialist. In this role, you will be responsible for managing production documentation, including the creation, revision, and issuance of electronic Manufacturing Batch Records and Equipment Specifications. You will also oversee production changes...
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Production Documentation Specialist
1 mese fa
Pisa, Toscana, Italia Takeda A tempo pienoAbout the Role:Takeda is seeking a highly skilled professional to join our team as a Production Documentation Specialist. In this role, you will be responsible for managing production documentation, including the creation, revision, and issuance of electronic Manufacturing Batch Records and Equipment Specifications. You will also oversee production changes...
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Production Specialist
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Pisa, Toscana, Italia Takeda A tempo pienoAbout 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...
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Production Documentation Management Specialist
7 giorni fa
Pisa, Toscana, Italia Takeda A tempo pienoAbout 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...
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Production Documentation Specialist
2 settimane fa
Pisa, Toscana, Italia Takeda Pharmaceutical A tempo pienoAbout 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...
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Production Documentation Specialist
2 settimane fa
Pisa, Toscana, Italia Takeda A tempo pienoAbout 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...
Manufacturing Deviation and GMP Documentation Specialist
2 mesi fa
As the Manufacturing Deviation and GMP Documentation Lead, you will be responsible for overseeing 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 revision, approval, issuance, and maintenance (Master Batch Records, SOPs, forms, logbooks, visual aids) according to GDDP rules and cGMP compliance.
- Guarantee execution of training on production documentation of its ownership/department, ensuring 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 purposes.
- 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.
- 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 others.
- 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.
