CSV Analyst - Quality Control

at  Pharmaron

Job Introduction Quality Control Software Systems and Validation Analyst (CSV Analyst)UK - RUSHDEN We are looking for:

Our Chemistry Department in Rushden, have a new opening for a Software Systems and Validation Analyst to participate in validation of computerised systems and Data Integrity activities associated with the software system lifecycle. 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:

• Participate in the implementation and management of procedures to facilitate the testing and management of all scientific systems in Chemistry.
• Assist in the procurement process of Chemistry equipment and associated software.
• Perform computerised system and equipment validation in Chemistry.
• Maintain chemistry instruments and computerised systems in good working order and report any faults promptly.
• Ensure complete and accurate documentation of computerised systems life cycle is available, maintaining clear records and compliance.
• Review and update relevant SOPs and POLs to ensure compliance with regulatory requirements and to maintain best practices of industry.
• Compile Data Integrity GAP analyses templates and Risk Assessments for equipment and systems.
• Have the organisational skills to perform validation activities of instruments and associated computerised systems to agreed project timelines, communicating any scheduling issues to the QC System Manager /Supervisor if required.
• Work as part of a team to ensure that any project problems can be resolved promptly and accurately

Requirements:

• BSc Chemistry or relevant industrial experience.
• Effective communication skills both written and oral are required to communicate with colleagues and a wider audience.
• Good theoretical grounding of chromatographic and spectroscopic techniques.
• Excellent computer literacy skills are essential as work will be heavily focused on software and applications
• Knowledge of quality/regulatory standards and quality systems (in particular the relationship of the MHRA with the pharmaceutical industry) is desirable.
• Ability to learn new information quickly and apply this practically.
• 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.

• 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 Software Systems and Validation 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.

Pharmaron is a premier R&D service company supporting the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities having established diverse drug R&D service capabilities, ranging from synthetic, medicinal, and analytical chemistry, biology, DMPK, pharmacology, drug safety assessment, radiochemistry and isotopically labelled metabolism, chemical & pharmaceutical development to clinical development. With operations in China, US and UK staffed by over 19,000 employees, Pharmaron has an excellent track record in the delivery of R&D solutions to its partners in North America, Europe, Japan, and China

• Participate in the implementation and management of procedures to facilitate the testing and management of all scientific systems in Chemistry.
• Assist in the procurement process of Chemistry equipment and associated software.
• Perform computerised system and equipment validation in Chemistry.
• Maintain chemistry instruments and computerised systems in good working order and report any faults promptly.
• Ensure complete and accurate documentation of computerised systems life cycle is available, maintaining clear records and compliance.
• Review and update relevant SOPs and POLs to ensure compliance with regulatory requirements and to maintain best practices of industry.
• Compile Data Integrity GAP analyses templates and Risk Assessments for equipment and systems.
• Have the organisational skills to perform validation activities of instruments and associated computerised systems to agreed project timelines, communicating any scheduling issues to the QC System Manager /Supervisor if required.
• Work as part of a team to ensure that any project problems can be resolved promptly and accuratel