Method Transfer Specialist

hace 2 días


España GlaxoSmithKline A tiempo completo

Site Name: GSK Aranda de Duero, BurgosPosted Date: Nov 26 2024Method Transfer SpecialistWe create a place where people can grow, be their best, be safe, and feel welcome, valued, and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.Role Overview:GSK is seeking a skilled Method Transfer Specialist to play a pivotal role in transfer of analytical methods across the organization. The successful candidate will ensure compliance with regulatory guidelines, including Compendial (USP, EP, JP) and ICH requirements, and will be responsible for Out-of-Specification (OOS) investigations as part of ensuring robust analytical performance. This position offers an opportunity to lead diverse projects, requiring expertise in analytical method transfer and a working knowledge of statistics to ensure data integrity and regulatory compliance.Temporary role (12 - 18 months)Key Responsibilities:Lead and execute analytical method validation, verification, and transfer activities in compliance with GSK standards, regulatory requirements, and best practices. Develop, review, and approve method validation protocols, reports, and related documentation.Ensure analytical methods comply with Compendial (USP, EP, JP) and ICH guidelines. Perform statistical analysis and provide critical interpretation of validation data to support decision-making.Investigate and resolve Out-of-Specification (OOS) results, ensuring root cause analysis and implementation of corrective actions.Manage the planning, resource allocation, and risk identification for method validation and transfer projects to ensure timely completion.Collaborate with cross-functional teams, including quality control, regulatory, and manufacturing, to ensure the seamless transfer of analytical methods between sites. Communicate project status, challenges, and risk mitigation strategies to stakeholders and senior management.Participate in and support internal and external audits, as well as regulatory inspections. Maintain a continuous improvement mindset to optimize analytical procedures and workflows.Qualifications and Skills:Bachelor's, Master's, or Ph.D. in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related field.Substantial experience in analytical method validation, verification, and transfer within the pharmaceutical industry.Strong understanding of regulatory requirements, including Compendial (USP, EP, JP) and ICH guidelines.Demonstrated ability to conduct and lead OOS investigations, including documentation and resolution.Proven project management skills, with experience in resource estimation and team leadership.Strong communication and collaboration skills for cross-functional teamwork.Detail-oriented with a commitment to compliance, quality, and data integrity.Advance English level C1.Preferred Qualifications:If you have the following characteristics, it would be a plus:Basic knowledge of statistics and statistical software for validation data analysis.Job Posting end date: 03/12/2024Why GSK?Uniting science, technology and talent to get ahead of disease together.GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
#J-18808-Ljbffr



  • España buscojobs España A tiempo completo

    Meet CemexWe are a leading sustainable construction materials and solutions company with innovation and sustainability at its core working to create value for its stakeholders. Cemex’s global presence is strategically positioned across the Americas, the Caribbean, Europe, Africa, the Middle East, and Asia. Our global trading network is close to 100...


  • España Ethikos 3.0 A tiempo completo

    Our client is one of the non-profit organizations with the greatest impact in conflict areas, and they are looking for Digital Workplace Technical Support Level II Infrastructure for their offices in Barcelona.Overview: The IT Infrastructure Specialist plays a crucial role in maintaining and optimizing the various components of our IT infrastructure.This...

  • Product Support Engineer

    hace 18 horas


    España buscojobs España A tiempo completo

    Alight strives to provide "best in class" offerings and IP-enabled services for our customers. The Product Support Engineer Specialist is a member of the extended Product Engineering team and is responsible for ensuring Alight’s Payroll Solution is operating smoothly and enables users to conduct their day-to-day business as expected.The Product Solution...


  • España City Wide Facility Solutions A tiempo completo

    City Wide Facility Solutions is actively seeking a Business Development Specialist for our Franchise location in Northwest Ohio.Do you have experience in a lead generation or social media role? Do you enjoy setting up potential leads for sales? Are you looking for opportunity to make commission AND enjoy a competitive base? If you answered YES, we would like...

  • Tax Specialist

    hace 4 semanas


    España Uriach A tiempo completo

    ¿Quieres formar parte de nuestro equipo de Finanzas? Si te gusta....Supervisar la contabilidad y las finanzas, asegurando la precisión de los informes financieros, gestionando presupuestos, y garantizando el cumplimiento de las normativas financieras.Responsabilidades- Asistencia en el diseño y modelación de las políticas de precios de transferencia del...

  • Tax Specialist

    hace 2 días


    España buscojobs España A tiempo completo

    ¿Quieres formar parte de nuestro equipo de Finanzas? Si te gusta....Supervisar la contabilidad y las finanzas, asegurando la precisión de los informes financieros, gestionando presupuestos, y garantizando el cumplimiento de las normativas financieras.ResponsabilidadesAsistencia en el diseño y modelación de las políticas de precios de transferencia del...

  • Category Specialist

    hace 4 semanas


    España PuroClean Certified Restoration Specialist of Auburn A tiempo completo

    JOB PURPOSEProvide internal and external relevant information and data flow to the demand organization to ensure customer centricity and consumer driven decisions. Create and coordinate the Category Management Vision, design strategies, identify potential and initiate projects that will ensure category growth and RC market share, through the development of...


  • España Amazon A tiempo completo

    Amazon Vendor Services (AVS) is a paid B2B service that aims to help strategic brands partner with Amazon.As a Supply Chain Specialist in the AVS team, you will own the relationship with your brand focusing on supply chain management and advise your key account and supply chain management partners as a business expert. At the same time, you will gain...


  • España Almirall Hermal GmbH A tiempo completo

    Select how often (in days) to receive an alert:CMC Biologics Analytical Senior ScientistMissionDay-to-day oversight of analytical activities performed at partnered CDMOs and CROs according to latest industry standards and regulatory guidance.Contribution to set up and development of in-house/outsource analytical activities.Definition of DS & DP specification...

  • Product Specialist EMEA

    hace 4 semanas


    España Axalta Coat. Sys. Spain A tiempo completo

    Axalta has remained at the forefront of the coatings industry by continually investing in innovative solutions. We engineer technologies that protect customers’ products – whether they are battling heat, light, corrosion, abrasion, moisture, or chemicals – and add dimension and beauty with colorful finishes. We have a vast and ever-evolving portfolio...


  • España ALL WE WEAR GROUP A tiempo completo

    Who are we... All We Wear Group (AWWG) is the global fashion group that integrates the brands Pepe Jeans London, Hackett, and Façonnable, and is the licensed distributor for Tommy Hilfiger, Calvin Klein, Karl Lagerfeld, DKNY, and Donna Karan in Spain and Portugal.The project! As a Retail Operations Specialist, you will be providing back office support for...


  • España Nestlé SA A tiempo completo

    Position SummaryAs a Trade Asset Specialist at Nestlé Professional, you will be at the forefront of ensuring the flawless operation and maintenance of our trade assets, such as coffee and beverages machines. In close collaboration with Sales Teams, Operations and External providers, your primary responsibility will be to manage the technical support and...

  • Tax Specialist Spain

    hace 4 semanas


    España International Paper A tiempo completo

    Tax Specialist SpainUbication:Madrid HODepartment/Area:FinanceWhy this is job for youAs the Tax Specialist for Spain, you will ensure smooth daily tax operations and compliance in Spain. You will work with regional business teams, the Polish Shared Services Center, the EMEA tax department, and external parties like tax auditors and consulting firms. The role...

  • Tax Specialist Spain

    hace 4 semanas


    España International Paper A tiempo completo

    Tax Specialist Spain Ubication : Madrid HO Department / Area : Finance Why this is job for you As the Tax Specialist for Spain, you will ensure smooth daily tax operations and compliance in Spain. You will work with regional business teams, the Polish Shared Services Center, the EMEA tax department and external parties like tax auditors and consulting...

  • Tax manager

    hace 4 semanas


    España Blu Selection A tiempo completo

    Are you a Tax Specialist searching for a new opportunity in Barcelona? Do you have high quality stakeholder experience and an ability to make clean/organised reports? We have the perfect opportunity for you!Your responsibilities and impact working as a Tax Specialist will be:Be the reporting manager of one junior tax specialist.Complete high level checks in...


  • España All We Wear Group A tiempo completo

    Who are we... All We Wear Group (AWWG) is the global fashion group that integrates the brands Pepe Jeans London, Hackett, and Façonnable, and is the licensed distributor for Tommy Hilfiger,Calvin Klein Karl Lagerfeld, DKNY and Donna Karan in Spain and Portugal. The project! As a Retail Operations Specialist you will be providing back office support for...


  • España Puratos A tiempo completo

    At Puratos, we create innovative food solutions for the health and well-being of people everywhere. As the global leader in bakery, patisserie and chocolate ingredients, we help our customers to be successful with their business, by turning technologies and experiences from food cultures around the world into new opportunities.To strengthen our team in Sils...


  • España Nestlé SA A tiempo completo

    Position SummaryAs a Trade Asset Specialist at Nestlé Professional, you will be at the forefront of ensuring the flawless operation and maintenance of our trade assets, such as coffee and beverages machines. In close collaboration with Sales Teams, Operations and External providers, your primary responsibility will be to manage the technical support and...

  • Tax Specialist Spain

    hace 2 semanas


    España International Paper A tiempo completo

    Tax Specialist Spain Ubication: Madrid HO Department/Area: Finance Why this is job for you As the Tax Specialist for Spain, you will ensure smooth daily tax operations and compliance in Spain. You will work with regional business teams, the Polish Shared Services Center, the EMEA tax department and external parties like tax auditors and consulting firms....

  • Product Specialist EMEA

    hace 3 semanas


    España Axalta Coating Systems A tiempo completo

    Axalta has remained at the forefront of the coatings industry by continually investing in innovative solutions. We engineer technologies that protect customers’ products – whether they are battling heat, light, corrosion, abrasion, moisture, or chemicals – and add dimension and beauty with colorful finishes. We have a vast and ever-evolving portfolio...