CSV Technical Specialist

4 weeks ago

Rushden, Northamptonshire, United Kingdom Pharmaron Full time
Key Responsibilities:

As a CSV Technical Specialist at Pharmaron, you will be responsible for conducting thorough validations of software systems and equipment used in the Metabolism department. You will also prepare and manage comprehensive documentation for software validations, ensuring compliance with regulatory requirements. Additionally, you will support the implementation of tools and procedures to streamline testing and document management processes. Furthermore, you will ensure that system validation SOPs align with regulatory requirements and industry standards. You will also participate in Sponsor and regulatory audits and drive continuous improvement initiatives for software systems and support focus teams in resolving compliance issues.

Requirements:

To be successful in this role, you will need a MSc or BSc in Chemistry/Biochemistry/Biomedical Sciences or related subject or a qualification in Computer Science. You will also need experience of successfully completing software validations in a GxP environment. Furthermore, you will need experience using Project Management techniques that can be transferred. You will also need effective written and verbal communication skills, including the ability to effectively present technical information to colleagues and clients. Additionally, you will need effective organisational and time management skills, problem solving skills, good knowledge of Microsoft Office software and the ability to work within and contribute to a multi-disciplined environment. Finally, you will need a basic understanding of IT concepts such as client/server architectures, filesystems, and user access control.

Our Company:

Pharmaron is a dynamic, fast-growing company with an enviable reputation for leading edge science. We offer contract research services to some of the world's leading pharmaceutical companies, solving what were believed to be unsolvable scientific challenges. We believe in our ability to relentlessly push forward the boundaries of scientific excellence, delivering solutions for our clients, always operating ethically and with integrity. We take pride in our professionalism and commitment to always deliver our very best work. Our Rushden site is a centre of excellence for Radiolabelled Sciences incorporating both Metabolism and Chemistry. We offer our employees a supportive teamwork environment, enabling them to develop and liberate their true potential. We offer a competitive salary and a progressive and comprehensive suite of employee benefits, a state of the art working environment and the opportunity for growth and development and will support funding for relevant training and development programmes.

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