CSV Technical Specialist

1 month ago

Rushden, Northamptonshire, United Kingdom Pharmaron Full time
Job Title: CSV Technical Specialist

We are seeking a detail-oriented CSV Technical Specialist to join our team at the Rushden Metabolism facility. As a key member of our team, you will play a crucial role in ensuring the integrity and compliance of our computerized 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 organizational 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, 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.

Based in Northamptonshire, our Rushden site is a centre of excellence for Radiolabelled Sciences incorporating both Metabolism (which includes Clinical Metabolism, Pre-clinical ADME, In vitro and DDI services, Large Molecule Metabolism, Environmental Fate, Plant Metabolism and Metabolite Identification) in addition to Chemistry (which includes API and IMP manufacture).

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.

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.

Why Should You Apply?
  • This is an opportunity for you as a CSV Technical Specialist to make a real impact in a highly scientific and regulated environment, demonstrate leadership, ambition, and the desire to grow with the department.
  • Build and shape your career in an environment that sets and commits to the highest standards of Chemistry.
  • To be part of a team who support each other, embrace and solve technical challenges and put excellence at the heart of all that we do.

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