Manufacturing Deviation And Gmp Documentation Lead
6 mesi fa
By 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 Description 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 documentation (SOPs, MBRs, JA, etc…) by assuring strong training efficacy.
logistic activities for manufacturing and visual inspection.
revision of production documentation per GDP compliance.
data management for trending purpose.
Assure management of Production Deviation, that includes investigation and CAPA.
Assure management of identification of gaps in manufacturing/visual inspection to fix those; assure identification/execution of the optimization on the shop floor.
Assure collaboration for audit execution.
Management of direct people involved in Production documentation, Logistic activities, Deviation management, optimization on the shop floor, identification/resolution of gaps in manufacturing and visual inspection.
Receives assignment in the form of objectives and establishes goals to meet objectives; provide guidance to subordinates to achieve goals in accordance with established policies, review/monitor goals of the team.
Person in charge for security. ACCOUNTABILITIES: . Guarantee Production documentation critical revision approval, issuance, maintenance (Master Batch Records, SOPs, forms, logbooks, visual aid) according to GDDP rules and cGMP compliance.
Guarantee execution of training on Production documentation of its ownership/department by assuring 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 purpose. 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. WHAT YOU BRING TO TAKEDA Degree in scientific disciplines (Chemistry & Pharmaceutical Technologies, Biology, Biotechnology, Chemistry).
At least 5 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
More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. 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.
Empowering our people to shine:
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.
Locations
ITA - Pisa Worker Type
Employee Worker Sub-Type
Regular Time Type
Full time
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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
3 settimane fa
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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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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Pisa, Italia Takeda A tempo pienoJob Title: Manufacturing Deviation and GMP Documentation LeadLocation: PisaOBJECTIVES/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 documentation (SOPs,...
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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
4 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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Pisa, Italia Takeda 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'sPrivacy 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 Lead
4 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, 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, 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...
-
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...
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Manufacturing Deviation and GMP Documentation Lead
3 settimane fa
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...
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Manufacturing Deviation and GMP Documentation Specialist
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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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Pisa, Italia Takeda 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, Italia Takeda A tempo pienoDescription Job Title: Manufacturing Deviation and GMP Documentation Lead Location : Pisa 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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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...
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Manufacturing Deviation and GMP Documentation Lead
2 settimane fa
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
4 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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Manufacturing Deviation and GMP Documentation Specialist
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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...
