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.
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.
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