Technical Specialist – CSV

3 weeks ago

Rushden, United Kingdom Pharmaron Full time
We are looking for:

A CSV Technical Specialist to conduct validation of regulated software systems and other activities associated with the software system lifecycle at our Rushden Metabolism facility.At Pharmaron we offer: Vibrant and dynamic employment –  we are a highly specialised, growth company operating in a critical sector of the economy – our future is strong and exciting Opportunities to develop your skills and yourself –  our rapid growth brings greater opportunities for you to learn and grow faster A great team where we all support each other –  enjoy your work – after all you spend about a third of your time here Key roles and responsibilities: Conduct validations of software and equipment. Prepare and manage documentation for software validations Ensure compliance of computer systems with regulatory requirements. Quality Control documents prepared for validation projects Act as System Owner for key software in the Metabolism department. Act as eArchivist for the relevant software systems. Support the implementation of tools and procedures to facilitate testing and document management of all software systems. Ensure compliance of system validation SOPs with regulatory requirements. Ensure consistency of systems validation SOPs with best practices of industry. Ensure complete and accurate documentation of computer systems. Participate in Sponsor audits. Support continuous improvement of software systems. Support focus teams to resolve compliance issues. Requirements: Essential MSc or BSc in Chemistry/Biochemistry / Biomedical Sciences or related subject or a qualification in Computer Science  Experience working in a GLP facility Desirable Experience in Metabolism in a CRO, Pharmaceutical or Agrochemical company using the Lablogic suite of software Experience of successfully completing software validations in a GXP environment Knowledge of the studies and equipment used in Metabolism, Environmental Fate and Bioanalysis studies Our Company:  “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 Rushden 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 professional to make a real impact in a highly scientific and regulated environment, demonstrate 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 and Quality. This is an opportunity to work in an environment when no two days are the same 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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