CSV Analyst, Metabolism
Pharmaron is seeking a CSV Analyst to join our team at the Rushden Metabolism facility. As a key member of our team, you will ensure the integrity and compliance of our computerised systems. If you have an understanding of software validation principles and a passion for ensuring quality and compliance, we invite you to apply to join our team at Pharmaron.
At Pharmaron we offer:
1. 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!
2. Opportunities to develop your skills and yourself – our rapid growth brings greater opportunities for you to learn and grow faster!
3. 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:
4. Perform computerised system and equipment validation in the Metabolism department
5. Maintain instruments and computerised systems in good working order and report any faults promptly.
6. Ensure complete and accurate documentation of computerised systems life cycle is available, maintaining clear records and compliance.
7. Ensure complete and accurate documentation of computerised systems life cycle is available, maintaining clear records and compliance.
8. Ensure that system validation SOPs align with regulatory requirements and industry standards.
9. Participate in Sponsor and regulatory audits.
Requirements:
10. MSc or BSc in Chemistry/Biochemistry/ Biomedical Sciences or related subject or a qualification in Computer Science
11. Effective communication skills both written and oral are required to communicate with colleagues and a wider audience.
12. Excellent computer literacy skills are essential as work will be heavily focused on software and applications
13. Knowledge of quality/regulatory standards and quality systems (in particular the relationship of the MHRA with the pharmaceutical industry) is desirable.
14. Ability to learn new information quickly and apply this practically.
15. Effective time management skills and ability to work to tight deadlines.
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.
16. We offer a competitive salary and a progressive and comprehensive suite of employee benefits.
17. We offer state of the art working environment in our specialist Rushen site.
18. We offer the opportunity for growth and development and will support funding for relevant training and development programmes.
Why Should You Apply?
19. This is an opportunity for you as a CSV Analyst to make a real impact in a highly scientific and regulated environment, demonstrate leadership, ambition and the desire to grow with the department.
20. Build and shape your career in an environment that sets and commits to the highest standards of Chemistry.
21. 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.