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CSV Technical Specialist

2 months ago

Rushden, Northamptonshire, United Kingdom Pharmaron Full time
About the Role

We are seeking a highly skilled CSV Technical Specialist to join our team at Pharmaron's Rushden Metabolism facility. As a key member of our team, you will play a crucial role in ensuring the integrity and compliance of our computerised systems.

Key Responsibilities
  • Conduct thorough validations of software systems and equipment used in the Metabolism department.
  • Prepare and manage comprehensive documentation for software validations, ensuring compliance with regulatory requirements.
  • Support the implementation of tools and procedures to streamline testing and document management processes.
  • Ensure that system validation SOPs align with regulatory requirements and industry standards.
  • Participate in Sponsor and regulatory audits.
  • Drive continuous improvement initiatives for software systems and support focus teams in resolving compliance issues.
Requirements
  • MSc or BSc in Chemistry/Biochemistry/Biomedical Sciences or related subject or a qualification in Computer Science.
  • Experience of successfully completing software validations in a GxP environment.
  • Experience using Project Management techniques that can be transferred.
  • Effective written and verbal communication skills, including the ability to effectively present technical information to colleagues and clients.
  • Effective organisational and time management skills.
  • Problem solving.
  • Good knowledge of Microsoft Office software.
  • Work within and contribute to a multi-disciplined environment.
  • Basic understanding of IT concepts such as client/server architectures, filesystems, and user access control.
About Us

We are a dynamic, fast-growing company, with an enviable reputation for leading edge science, offering contract research services to some of the world's leading pharmaceutical companies. 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 offer a competitive salary and a progressive and comprehensive suite of employee benefits. We offer state of the art working environment in our specialist Rushen site. We offer the opportunity for growth and development and will support funding for relevant training and development programmes.