Gmp Compliance Documentation Specialist
1 mese 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 Compliance Documentation Lead
4 settimane fa
Pisa, Toscana, Italia Takeda Pharmaceutical A tempo pienoAbout 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...
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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 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 Specialist
4 settimane fa
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, 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 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...
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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...
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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 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 (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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Production Documentation Specialist
1 mese fa
Pisa, Toscana, Italia Takeda A tempo pienoPurpose and ScopeThe 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 ResponsibilitiesExecute...
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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, 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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Pharmaceutical Compliance Specialist
4 settimane fa
Pisa, Toscana, Italia Takeda A tempo pienoWe 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...
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Compliance & Privacy Specialist (Italy)
1 mese fa
Pisa, Italia Grifols Italia SpA A tempo pienoWould you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and...
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Compliance & Privacy Specialist (Italy)
1 mese fa
Pisa, Italia Grifols, S.A A tempo pienoWould you like to join an international team working to improve the future of healthcare?Do you want to enhance the lives of millions of people?Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world.We are leaders in plasma-derived medicines and transfusion medicine and develop,...
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Changes Specialist
6 mesi fa
Pisa, Italia Takeda Pharmaceutical A tempo pienoSarà considerato requisito preferenziale l'appartenenza alle categorie protette (legge n. 68/99)_ **Job Title: Changes Specialist** **Location: Pisa** **_ OBJECTIVES/PURPOSE:_** As a Changes Specialist you will oversee the management of all activities related to production documentation ownership, including revision, issuance, and maintenance of...
