Production Documentation Specialist
1 settimana fa
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 important. Moreover, leading projects that enhance production processes and continuous improvement initiatives are key responsibilities.
Key Responsibilities:
- Complete Electrical Manufacturing Batch Record (MES), Equipment Specification (ESP) and related procedures revision, approval, issuance and related SOPs, according to GDDP rules and cGMP compliance.
- Implement training of Production documentation of its ownership.
- Be part of the execution of the Change Control as SME for production and support those through risk assessment (quality risk management).
- Collaborate with regulatory authorities' audits.
Requirements:
- A degree in Chemistry, Pharmaceutical Technologies, Biology, Biotechnology, or related engineering fields.
- Experience in pharmaceutical industry, especially in aseptic production.
- Regulatory Knowledge: Proficiency in GMP regulations, sterile manufacturing, RABS, and Isolators.
- Analytical Skills: critical thinking, problem-solving, and application of scientific methods.
- A team player able to collaborate across dynamic departments.
- Technological Proficiency: Digital and innovation orientation, familiarity with IT applications like Word, Excel, PowerPoint, and Trackwise System.
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.
Equal Employment Opportunities:
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.
-
Production Documentation Specialist
15 ore 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...
-
Production Documentation Specialist
4 settimane fa
Pisa, Toscana, Italia Takeda A tempo pienoAbout the Role:Takeda is seeking a 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 and...
-
Production Documentation Specialist
2 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...
-
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...
-
Production Documentation Specialist
1 mese fa
Pisa, Toscana, Italia Takeda A tempo pienoAbout the Role:Takeda is seeking a 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 and...
-
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...
-
Production Documentation Specialist
5 giorni 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...
-
Production Documentation Specialist
6 giorni 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...
-
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...
-
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...
-
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...
-
Pisa, Toscana, Italia Takeda Pharmaceutical A tempo pienoAbout the RoleAs 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...
-
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...
-
GMP Compliance Specialist
2 mesi fa
Pisa, Toscana, Italia Takeda Pharmaceutical A tempo pienoAbout the RoleWe are seeking a highly skilled Manufacturing Deviation and GMP Documentation Lead to join our team at Takeda Pharmaceutical. As a key member of our manufacturing team, you will be responsible for overseeing the management of all activities related to GMP production documentation.Key ResponsibilitiesGuarantee Production documentation critical...
-
Pisa, Toscana, Italia Takeda Pharmaceutical A tempo pienoAbout the RoleWe are seeking a highly skilled Manufacturing Deviation and GMP Documentation Lead to join our team at Takeda Pharmaceutical. As a key member of our production team, you will be responsible for ensuring the accuracy and compliance of our GMP production documentation.Key ResponsibilitiesGuarantee the critical revision, approval, issuance, and...
-
Manufacturing Deviation and GMP Documentation Lead
4 settimane fa
Pisa, Toscana, Italia Takeda A tempo pienoJob Title: Manufacturing Deviation and GMP Documentation LeadJob Summary:Takeda is seeking a highly skilled Manufacturing Deviation and GMP Documentation Lead to join our team. 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,...
-
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...
-
Manufacturing Deviation and GMP Documentation Lead
1 settimana 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...
-
Pisa, Toscana, Italia Takeda A tempo pienoJob Title: Manufacturing Deviation and GMP Documentation LeadAbout 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...
-
Pisa, Toscana, Italia Takeda A tempo pienoJob Title: Manufacturing Deviation and GMP Documentation LeadLocation: PisaJob Summary:Takeda is seeking a highly skilled Manufacturing Deviation and GMP Documentation Lead to join our team in Pisa. 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...
