Manufacturing Deviation And Gmp Documentation Lead

2 settimane fa

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 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.
- 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.
- 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

  • Manufacturing Deviation and Gmp Documentation Lead

    7 mesi fa

    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...

  • Manufacturing Deviation and Gmp Documentation

    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**: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,...

  • Manufacturing Deviation And Gmp Documentation

    5 giorni fa

    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, issuance,...

  • Manufacturing Deviation And Gmp Documentation Lead

    3 mesi 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...

  • Manufacturing Deviation And Gmp Documentation Lead

    3 mesi 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...

  • Manufacturing Documentation Compliance Specialist

    2 giorni fa

    Pisa, Toscana, Italia Takeda Pharmaceutical A tempo pieno

    About the RoleTakeda is seeking a highly skilled Manufacturing Documentation Compliance Specialist to join our team in Pisa, Italy.Key Responsibilities:Serve as the primary point of contact for all GMP production documentation activities, ensuring compliance with Good Distribution Practice (GDP) and Current Good Manufacturing Practices (cGMP).Develop,...

  • Manufacturing Documentation Compliance Specialist

    3 settimane fa

    Pisa, Toscana, Italia Takeda Pharmaceutical A tempo pieno

    About the Role: We are seeking a highly skilled Manufacturing Documentation Compliance Specialist 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.Responsibilities:Guarantee...

  • Deviation Specialist

    7 mesi fa

    Pisa, Italia Takeda Pharmaceutical A tempo pieno

    **Sarà considerato requisito preferenziale l'appartenenza alle categorie protette** (legge n. 68/99) **Role: Deviation Specialist** **Location: Pisa** **_ OBIETTIVI/SCOPO _**_(3-4 punti)_ - Gestione delle deviazioni occorse in ambito manufacturing/ispezione visiva. - Supporto del miglioramento continuo in produzione. - Gestione delle procedure di...

  • Deviation Specialist

    2 settimane fa

    Pisa, Italia Takeda Pharmaceutical A tempo pieno

    **Sarà considerato requisito preferenziale l'appartenenza alle categorie protette** (legge n. 68/99)**Role: Deviation Specialist****Location: Pisa****_ OBIETTIVI/SCOPO _**_(3-4 punti)_- Gestione delle deviazioni occorse in ambito manufacturing/ispezione visiva.- Supporto del miglioramento continuo in produzione.- Gestione delle procedure di...

  • Sterility Assurance Lead

    6 mesi fa

    Pisa, Italia Takeda Pharmaceutical A tempo pieno

    **Job Title: Sterility Assurance Lead**: **Location: Pisa**: **The Sterility Assurance Lead will ensure that the production processes for the manufacturing of sterile products are executed following cGMP/Annex 1 regulations and in adherence to the internal and global procedures. The Sterility Assurance Lead must have strong expertise in aseptic practices and...

  • Sterility Assurance Lead

    3 settimane fa

    Pisa, Italia Takeda Pharmaceutical A tempo pieno

    **Job Title: Sterility Assurance Lead**:**Location: Pisa**:**The Sterility Assurance Lead will ensure that the production processes for the manufacturing of sterile products are executed following cGMP/Annex 1 regulations and in adherence to the internal and global procedures. The Sterility Assurance Lead must have strong expertise in aseptic practices and...

  • Quality Control Lead

    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**:Quality Control Lead **Location**:Pisa **Key Responsibilities of Quality Control Lead are the following**: - Leading all areas in the Laboratory, providing support and strategy in the following activities: - Laboratory testing - Laboratory...

  • Process Engineering Lead

    4 settimane 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 On The Shop Floor

    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: Quality on the shop floor** **Location: Pisa - Italy** Key Responsibilities of Quality on the shop floor are the following: - Ensure compliance with regulatory requirements; develop and maintain standard operating procedures (SOPs) for...

  • 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...

  • Lead Visual Inspector

    7 giorni fa

    Pisa, Toscana, Italia Takeda Pharmaceutical A tempo pieno

    Job Title: Lead Visual InspectorWe are seeking a highly skilled Lead Visual Inspector to join our team at Takeda Pharmaceutical. As a key member of our quality assurance department, you will be responsible for leading and developing our visual inspection team.Estimated Salary: $100,000 - $130,000 per yearAbout the Job:You will lead and develop the visual...

  • Programme Lead

    2 settimane fa

    Pisa, Toscana, Italia ION A tempo pieno

    Pave the Way for Success as a Programme Lead at IONJoin our team of innovative thinkers and make a real impact as a Programme Lead. With your expertise, you will be instrumental in driving the delivery of high-quality results across multiple projects, working closely with product development, delivery, sales, and finance teams.We're seeking an experienced...

  • Quality On The Shop Floor

    7 giorni fa

    Pisa, Italia Takeda Pharmaceutical A tempo pieno

    **Sarà considerato requisito preferenziale l'appartenenza alle categorie protette** (legge n. 68/99)**Job Title: Quality on the shop floor****Location: Pisa - Italy**Key Responsibilities of Quality on the shop floor are the following:- Ensure compliance with regulatory requirements; develop and maintain standard operating procedures (SOPs) for sterile...

  • 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...