CSV Quality Assurance Officer

Simbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseases. Perfectly structured, we provide full-service clinical development solutions for small and mid-size drug developers – headed up by a centralised leadership team.

With a focus on tailormade and scalable solutions, we’ll adapt our delivery style, communications and operations to suit the demands of the project, helping clients achieve their clinical and commercial objectives. Because our goal is the same as theirs; to improve patients’ lives.

We are looking for a CSV Quality Assurance Officer to join our Quality Assurance team where you will have specific responsibility for Quality Assurance oversight and support for Simbec-Orion’s computerised system validation activities. You will develop skills and experience in CSV QA whilst working under the supervision and guidance of a Senior CSV Quality Assurance Officer. In addition you will carry out all assigned responsibilities within the QA department, including conducting audits, document reviews, SOP and process development, non-compliance management, CAPA follow-up, training, QA consultancy internally and externally, and will support QA and operational process improvement initiatives.

You will lead in enhancing a ‘Quality First’ culture delivering Quality by Design services that deliver Patient Safety, Data Integrity and Regulatory Compliance across all of our operational departments. You will apply a risk based, data driven, approach across the organisation to build, consolidate, and improve identification of risk, taking appropriate mitigating action, and effectively managing quality issues.

Simbec-Orion is growing fast. To keep up with demand, we’re looking for the best people, from all areas of clinical development, to join our team.

We’re dedicated to bringing the latest advances in science to market. Exposure to truly innovative new drugs in patient populations with serious unmet medical needs is what drives our company – and your reason to be a part of it.

With experts from all disciplines under the same roof, you’ll work alongside some of the industry’s best. So if you’d like to further your career within challenging therapeutic areas in rare disease, oncology, or at our clinical pharmacology site, or laboratory services. We’re waiting to hear from you.