GMP Compliance Documentation Specialist
4 giorni fa
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 documentation critical revision, approval, issuance, and maintenance according to GDDP rules and cGMP compliance.Guarantee execution of training on production documentation, ensuring strong training efficacy.Guarantee logistic activities for manufacturing and visual inspection, including preparation and distribution of MBRs and VRs, creation of sampling labels, and revision of production documentation per GDP compliance.Guarantee execution/leading of investigations related to manufacturing/visual inspection department, applying appropriate tools and identifying/ executing related CAPAs when applicable.Collaborate with regulatory authorities' audits.Guarantee identification of gaps in manufacturing/visual inspection to fix those and identify/execute 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. 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.Takeda is proud in its 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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GMP Documentation Specialist
7 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
7 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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Gmp Compliance Documentation Specialist
6 giorni fa
Pisa, 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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GMP Compliance Documentation Specialist
5 giorni fa
Pisa, 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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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 A tempo pienoAbout 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...
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Pisa (PI), Italia Takeda Pharmaceutical A tempo pienoBy clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job...
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Pisa (PI), Italia Takeda Pharmaceutical A tempo pienoBy clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job...
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Manufacturing Deviation and GMP Documentation Specialist
1 settimana fa
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 Specialist
1 settimana fa
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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Pisa, Italia Takeda Pharmaceutical A tempo pieno**Sarà considerato requisito preferenziale l'appartenenza alle categorie protette** (legge n. 68/99) **Job Title**:Manufacturing Deviation & GMP Documentation Supervisor **Location**:Pisa **_ OBJECTIVES/PURPOSE: _** - Supervision and management of all activities related to all GMP production documentation; that includes: - critical revision, approval,...
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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
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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Pisa, Toscana, Italia Takeda Pharmaceutical A tempo pienoAbout 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...
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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
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, Italia Takeda Pharmaceutical A tempo pieno**Job Title**:Manufacturing Deviation and GMP Documentation Lead **Location**:Pisa **_ OBJECTIVES/PURPOSE:_** - Assure management of all activities related to all GMP production documentation; that includes: - critical revision, approval, issuance, maintenance of documentation according to GDDP rules, cGMP compliance. - execution of training on production...
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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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GMP Documentation and Manufacturing Lead
1 giorno fa
Pisa, Toscana, Italia Takeda A tempo pienoJob 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...
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Pisa, Italia Takeda Pharmaceutical A tempo pienoBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use.I further attest that all information I submit in my employment application is true to the best of my knowledge.Job...
