Changes Specialist

1 settimana fa

Pisa, Italia Takeda Pharmaceutical A tempo pieno

Sarà 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 documentation according to GDDP rules, ensuring cGMP compliance, and execution of related training. You will also be in charge of Production Changes, including related risk assessments.
**_ ACCOUNTABILITIES:_**
- Execute documentation revision, issuance, maintenance (Master Batch Records, SOPs, forms, logbooks, visual aid) according to GDDP rules and cGMP compliance.
- Execute effective training of Production documentation of its ownership.
- Execute Change Control activities with impacts on production and support those through adequate and strong risk assessment (quality risk management).
- Collaborate with regulatory authorities' audits.
- Execute production activities as support to process, cleaning validation and technical operation activities with impact on Production process/equipment.
**_ WHAT YOU BRING TO TAKEDA:_**
- Degree in scientific disciplines (Chemistry & Pharmaceutical Technologies, Biology, Biotechnology, Chemistry).
- 3-5 years of experience in pharmaceutical companies
- Deep knowledge of aspetic production process.
- Deep knowledge of GMP regulations and manufacturing of sterile products with RABS/Isolators.
- Organizational, analysis and prioritization ability.ommunication skills, ability to influence other.
- Flexibility, ability to rapid adaption to changes.
- Ability to take/propose decisions based on risk evaluation.
- Strong team-working ability and results orientation.
- Problem solving ability.
- Knowledge of Trackwise System is a plus.
- Oriented in digitalization/innovation of systems/process.
**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

  • Changes Specialist

    7 mesi fa

    Pisa, Italia Takeda Pharmaceutical A tempo pieno

    Sarà 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...

  • Project Manager

    4 settimane fa

    Pisa, Toscana, Italia Angel A tempo pieno

    Job Summary:We are seeking a highly motivated Project Manager - Process Optimization Specialist to support our project management team in the planning, execution and closure of projects.The successful candidate will collaborate with senior project managers and operational teams to ensure that projects are completed successfully, meeting established deadlines...

  • Innovative IT Support Specialist

    3 settimane fa

    Pisa, Toscana, Italia Stefanini A tempo pieno

    **Company Overview**Stefanini Group: A Brazilian company with over 35 years of experience in delivering IT services worldwide, ranging from IT outsourcing to application development or IT staffing. We have a direct presence in 41 countries, through our 70 offices located throughout the world.About Us: We are the preferred partner of many small-to-midsize...

  • Lead Machinery Safety Specialist

    5 mesi fa

    Pisa, Italia Amazon A tempo pieno

    At Amazon, we need talented and experienced individuals to help us operate safely and efficiently.As a Senior Workplace, Health and Safety (WHS) Specialist, your role is key to driving improvements on-site and at a regional level.You'll help your colleagues maintain high standards, all while driving a culture of safety and inclusivity on your site.There is a...

  • Lead Machinery Safety Specialist

    2 mesi fa

    Pisa, Italia Amazon A tempo pieno

    Job DescriptionAt Amazon, we need talented and experienced individuals to help us operate safely and efficiently. As a Senior Workplace, Health and Safety (WHS) Specialist, your role is key to driving improvements on-site and at a regional level. You'll help your colleagues maintain high standards, all while driving a culture of safety and inclusivity on...

  • Principal Machinery Safety Specialist

    1 mese fa

    Pisa, Italia Amazon A tempo pieno

    At Amazon, we need talented and experienced individuals to help us operate safely and efficiently. As a Senior Workplace, Health and Safety (WHS) Specialist, your role is key to driving improvements on-site and at a regional level. You'll help your colleagues maintain high standards, all while driving a culture of safety and inclusivity on your site.There is...

  • Lead Environmental Health

    4 settimane fa

    Pisa, Italia Amazon A tempo pieno

    At Amazon, we need talented and experienced individuals to help us operate safely and efficiently. As a Senior Workplace, Health and Safety (WHS) Specialist, your role is key to driving improvements on-site and at a regional level. You’ll help your colleagues maintain high standards, all while driving a culture of safety and inclusivity on your site.There...

  • Lead Environmental Health

    1 mese fa

    Pisa, Italia Amazon A tempo pieno

    At Amazon, we need talented and experienced individuals to help us operate safely and efficiently.As a Senior Workplace, Health and Safety (WHS) Specialist, your role is key to driving improvements on-site and at a regional level.You'll help your colleagues maintain high standards, all while driving a culture of safety and inclusivity on your site.There is a...

  • Lead Environmental Health

    1 mese fa

    Pisa, Italia Amazon A tempo pieno

    At Amazon, we need talented and experienced individuals to help us operate safely and efficiently. As a Senior Workplace, Health and Safety (WHS) Specialist, your role is key to driving improvements on-site and at a regional level. You'll help your colleagues maintain high standards, all while driving a culture of safety and inclusivity on your site.There is...

  • Engineering Graduates

    2 mesi fa

    Pisa, Italia Etinars A tempo pieno

    **WHO WE ARE** - **Etinars** is a **values-focused company** with **multi-year experience**, specializing in the **recruitment of professionals for niche markets** - managing the full lifecycle of specialist and executive-level hires. - At **Etinars**, we genuinely **care about who you are** and **what you need**. - We place great emphasis on **fostering...

  • Process Engineering Lead

    6 mesi fa

    Pisa, Italia Takeda Pharmaceutical A tempo pieno

    Sarà considerato requisito preferenziale l'appartenenza alle categorie protette (legge n. 68/99) **Job Title**:Pharma Process Engineering Lead **Location**: Pisa Job description **Responsibilities** - Ensures solid performance and efficiency of pharmaceutical machinery, aiming for operational excellence. - Leader of a department providing oversight to a...

  • Process Engineering Lead

    1 mese fa

    Pisa, Italia Takeda Pharmaceutical A tempo pieno

    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...

  • Process Engineering Lead

    3 settimane fa

    Pisa, Italia Takeda Pharmaceutical A tempo pieno

    Sarà considerato requisito preferenziale l'appartenenza alle categorie protette (legge n. 68/99)**Job Title**:Pharma Process Engineering Lead**Location**: PisaJob description**Responsibilities**- Ensures solid performance and efficiency of pharmaceutical machinery, aiming for operational excellence.- Leader of a department providing oversight to a high...

  • Process Engineering Lead

    1 mese fa

    Pisa, Italia Takeda Pharmaceutical A tempo pieno

    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...

  • Process Engineering Lead

    1 mese fa

    Pisa, Italia Takeda Pharmaceutical A tempo pieno

    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...

  • Process Engineering Lead

    1 mese fa

    Pisa, Italia Takeda Pharmaceutical A tempo pieno

    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...

  • Quality Engineer Multi-Core Systems

    2 mesi fa

    Pisa, Italia Enapter S.R.L. A tempo pieno

    About Enapter and what we do: Enapter is a rapidly-growing energy technology company with offices in Italy, Germany and Thailand.We develop and produce Anion Exchange Membrane (AEM) electrolysers that enable low-cost green hydrogen production at any scale.Enapter's mission is to make green hydrogen affordable and accessible to all.We are an international...

  • Quality Engineer Multi-Core Systems

    2 mesi fa

    Pisa, Italia Enapter S.R.L. A tempo pieno

    About Enapter and what we do: Enapter is a rapidly-growing energy technology company with offices in Italy, Germany and Thailand. We develop and produce Anion Exchange Membrane (AEM) electrolysers that enable low-cost green hydrogen production at any scale.Enapter's mission is to make green hydrogen affordable and accessible to all. We are an international...

  • Quality Engineer Multi-core Systems

    4 settimane fa

    Pisa, Italia Enapter S.r.l. A tempo pieno

    About Enapter and what we do:Enapter is a rapidly-growing energy technology company with offices in Italy, Germany and Thailand. We develop and produce Anion Exchange Membrane (AEM) electrolysers that enable low-cost green hydrogen production at any scale.Enapter’s mission is to make green hydrogen affordable and accessible to all. We are an international...

  • Quality Engineer Multi-Core Systems

    2 giorni fa

    Pisa, Italia Enapter S.R.L. A tempo pieno

    About Enapter and what we do: Enapter is a rapidly-growing energy technology company with offices in Italy, Germany and Thailand.We develop and produce Anion Exchange Membrane (AEM) electrolysers that enable low-cost green hydrogen production at any scale.Enapter's mission is to make green hydrogen affordable and accessible to all.We are an international...