Manufacturing Deviation and GMP Documentation Specialist
1 mese fa
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 production documentation critical revision, approval, issuance, and maintenance according to GDDP rules and cGMP compliance.
- Execute training on production documentation, ensuring strong training efficacy.
- Guarantee logistic activities for manufacturing and visual inspection, including preparation and distribution of MBRs and VRs.
- Collaborate with regulatory authorities' audits and identify gaps in manufacturing/visual inspection to fix those.
- Guarantee identification and execution of 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 and familiarity with 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 inspires and empowers employees 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.
What We Offer:
- A diverse and inclusive work environment.
- A global company with a rich history and a strong commitment to innovation.
- A competitive salary and benefits package.
- Opportunities for career growth and professional development.
- A collaborative and dynamic work environment.
Takeda is an equal opportunities employer and welcomes applications from diverse candidates.
Location: Pisa, Italy
Worker Type: Employee
Worker Sub-Type: Regular
Time Type: Full time
Language: English
Original Language Code: en
-
Manufacturing Documentation Compliance Specialist
1 settimana fa
Pisa, Toscana, Italia Takeda Pharmaceutical A tempo pienoAbout 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...
-
GMP Compliance Documentation Lead
1 mese 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...
-
Data and Analytics Specialist
2 mesi fa
Pisa, Toscana, Italia Ion Group A tempo pienoAbout the Role: We are seeking a skilled Data and Analytics Specialist to join our team at the Ion Group. This is an exciting opportunity for a talented individual to drive business growth through data-driven insights and strategic decision-making.Key Responsibilities: • Interact with business process owners to understand data generation and semantics •...
-
Safety and Compliance Specialist
4 settimane fa
Pisa, Toscana, Italia Amazon A tempo pienoAmazon is committed to providing a safe and healthy work environment for its employees. We are seeking an experienced Safety and Compliance Specialist to join our team.Job Description:In this role, you will be responsible for monitoring site performance against set KPIs and creating plans to improve processes. You will also set up workplace health and safety...
-
Global Manufacturing Operations HR Strategist
1 settimana fa
Pisa, Toscana, Italia Takeda A tempo pienoAt Takeda, we are committed to delivering innovative solutions that improve patient care. In this role as Global Manufacturing Operations HR Strategist, you will have the opportunity to drive business growth by developing and implementing a localized HR strategy aligned with our company's objectives.Job SummaryWe are seeking an experienced HR professional to...
-
Early Detection and Intervention Specialist
4 settimane fa
Pisa, Toscana, Italia EACD National Coordinators A tempo pienoThe EACD National Coordinators is seeking an Early Detection and Intervention Specialist to join our team. As a key member of our organization, you will play a crucial role in promoting research and education for the benefit of people with childhood-onset disabilities.Job DescriptionIn this position, you will be responsible for implementing early detection...
-
Workplace Health and Safety Specialist Lead
3 settimane fa
Pisa, Toscana, Italia Amazon A tempo pienoJob OverviewWe are seeking a highly skilled Workplace Health and Safety Specialist to join our team at Amazon. As a key member of our WHS department, you will be responsible for driving improvements in workplace health and safety across our sites.This is an exciting opportunity to work with a dynamic team and contribute to the development and implementation...
-
Senior HR Business Partner for Manufacturing Operations
4 settimane fa
Pisa, Toscana, Italia Takeda A tempo pienoAbout the RoleWe are seeking a highly experienced Senior HR Business Partner to join our team in Pisa, Italy. As a key member of our HR function, you will be responsible for providing strategic guidance and support to functional managers and employees at our manufacturing site.Key ResponsibilitiesDevelop and implement a localized HR strategy aligned with...
-
Innovative IT Support Specialist
1 settimana 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...
-
Mergers and Acquisitions Specialist
1 mese fa
Pisa, Toscana, Italia Link S.R.L. A tempo pienoTarget IdentificationAs an M&A Intern, you will conduct detailed assessments of potential target companies to align with Link S.R.L.'s strategic goals.Key Responsibilities:Build and maintain a robust list of target companies, including critical financial and shareholder information.Collaborate with the co-CEO and the management team to develop and refine...
-
Project Manager
2 settimane fa
Pisa, Toscana, Italia Angel A tempo pienoJob 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...
-
Esperto del Processo Farmaceutico Giunse Alto Livello
4 settimane fa
Pisa, Toscana, Italia Adecco Italia S.P.A. A tempo pienoSei alla ricerca di un'opportunità di crescita professionale nel settore farmaceutico? Stiamo cercando un Junior Esperto del Processo per un'azienda multinazionale a Pisa. La risorsa verrà inserita in stage all'interno dell'ufficio di Manufacturing Science e avrà il compito di supportare le attività del reparto riguardanti il monitoraggio e le iniziative...
-
Security Surveillance Specialist
7 giorni fa
Pisa, Toscana, Italia Amentum A tempo pienoAmentum seeks an experienced Security Surveillance Specialist to provide critical support in Italy. Estimated salary: $80,000 - $110,000 per year.Job Overview:As a Security Surveillance Specialist with Amentum, you will be responsible for identifying and mitigating security vulnerabilities in construction projects. This includes analyzing blueprints and...
-
Procurement Specialist
1 settimana fa
Pisa, Toscana, Italia Palmer Johnson A tempo pienoPalmer Johnson, a leading luxury yacht manufacturer, seeks an experienced Procurement Specialist to join their team in Pisa. Salary: €60,000 - €80,000 per annum (dependent on experience). The ideal candidate will have 5+ years of experience in procurement and contract negotiation. Key responsibilities include implementing procurement strategies,...
-
Construction Security Specialist
2 mesi fa
Pisa, Toscana, Italia Pittsburgh Hires Veterans A tempo pienoJob Title: Construction Security SpecialistJob Description:Job Summary: Pittsburgh Hires Veterans is seeking a skilled Construction Security Specialist to join our team. The successful candidate will be responsible for providing physical security support in Italy, ensuring the safety and security of the US Government mission.Key Responsibilities:* Perform...
-
Pisa, Toscana, Italia Enapter S.r.l. A tempo pienoAbout Enapter and Our MissionWe are a rapidly-growing energy technology company with offices in Italy, Germany, and Thailand. Our mission is to make green hydrogen affordable and accessible to all.As a Quality Assurance Specialist, you will play a crucial role in ensuring our products meet the required safety and quality standards.
-
Administrative Assistant
2 settimane fa
Pisa, Toscana, Italia European Gravitational Observatory A tempo pienoAbout the RoleWe are seeking an experienced Administrative Assistant to join our procurement team at the European Gravitational Observatory in Cascina, Italy. The successful candidate will work closely with our procurement office to manage tender procedures and administrative tasks.Job DescriptionThe selected candidate will be responsible for:Drafting...
-
Cloud Infrastructure Specialist
2 mesi fa
Pisa, Toscana, Italia Ion Group A tempo pienoAbout the JobWe are seeking a talented Cloud Infrastructure Specialist to join our team at the Ion Group. As a key member of our organization, you will play a crucial role in the development and implementation of our cutting-edge cloud solutions.ResponsibilitiesDesign and deploy scalable cloud infrastructure architecturesDevelop and maintain cloud-based...
-
Medical Advisor Italy
1 mese fa
Pisa, Toscana, Italia Octapharma A tempo pienoAbout the RoleWe are seeking an experienced Medical Advisor to join our team in Italy, responsible for developing collaborative relationships with specialists in Coagulation, Immunotherapy, and Critical Care areas. The ideal candidate will have a strong scientific background, excellent communication skills, and fluency in Italian, English, and French.Key...
-
Project Management Professional
1 mese fa
Pisa, Toscana, Italia Angel A tempo pienoJob DescriptionThe Junior Project Manager is a key role within our organization, supporting the project management team in the planning, execution, and closure of projects. This position collaborates with senior project managers and operational teams to ensure that projects are completed successfully, meeting established deadlines and budgets.This role...