- 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
- Lead and line manage appropriate team to who will maintain and validate computer software systems
- Ensure compliance of computer systems with regulatory requirements, including continual management of the Data Integrity program.
- In conjunction with the Technical Lead Software Validation lead all software and equipment validations in Metabolism.
- In conjunction with the Technical Lead Software Validation ensure compliance of system validation SOPs with regulatory requirements.
- In conjunction with the Technical Lead Software validation ensure consistency of systems validation SOPs with best practices of industry.
- Ensure complete and accurate documentation of computer systems.
- Participate in Sponsor audits.
- Lead continuous improvement of software systems.
- Identify gaps and lead focus teams to resolve compliance issues.
- Act as the liaison between the Metabolism Leadership Team and IT Management on the Rushden site.
- PhD, MSc or BSc (Hons) in Chemistry, Biochemistry , Biomedical Sciences or Computer Engineering
- Experience of successfully completing software validations in a GXP environment
- Scientific data interpretation, reporting and presentation skills
- Experienced Study Director in a GLP facility
- Line Management experience
- Effective written and verbal communication skills, including the ability to effectively present scientific findings to colleagues and clients
- Effective organisational and time management skills
- 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.
- This is an opportunity for you as a Technical professional 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.
Technical Lead - Rushden, United Kingdom - Pharmaron
Description
We are looking for:
Technical Lead to manage and maintain regulated computer systems for the Rushden Metabolism facility.
At Pharmaron we offer:
Key roles and responsibilities:
Requirements:
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.
Why Should You Apply?