Method Transfer Specialist

hace 2 semanas

Burgos, España Glaxosmithkline A tiempo completo

Site Name: GSK Aranda de Duero, Burgos
Posted Date: Nov 26 2024
Method Transfer Specialist We 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: 03/12/2024
Why 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.

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