CSV Quality Assurance Officer

ABOUT US: 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. THE ROLE: 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. KEY ACCOUNTABILITIES:

• Support the quality oversight of computer system validation projects for implementation and maintenance of computer systems.
• Provide assurance that projects, systems, solutions and services delivered by BSG meet internal standards and external regulatory requirements.
• Lead on assigned projects within the QA team.
• Oversee the implementation and appropriate update/improvement of the Quality Management System, including ongoing development and maintenance of QA systems and procedures.
• Produce and manage the Audit Schedule in collaboration with QA Management.
• Prepare and support Regulatory Inspections and Sponsor Audits in collaboration with QA Management.
• Generate and report on key quality indicators and Quality Assurance and Management reports.
• Escalate and follow up quality issues according to required timelines.
• Conduct audits and document reviews in line with the Audit Schedule and in accordance with the appropriate SOPs.
• Evaluate non-compliance actions (CAPA) and root cause analysis.
• Provide training to employees on Quality Assurance procedures and GxP.
• Maintain awareness and knowledge of current developments relevant GxPs, regulatory requirements/expectations and industry trends.
• Support operational departments through the provision of consultancy and guidance on Quality issues.

SKILLS REQUIRED: ESSENTIAL:

• Proven success working in a QA/Quality Management role within a (GxP) regulatory environment
• Experience in auditing to GxP quality standards across various audit types
• Experience/ Interest/ knowledge of computerised system validation framework, standards and regulations
• Excellent decision-making and problem-solving skills and proven experience in addressing significant non-compliance, including Root Cause Analysis, Corrective and Preventive Action
• High level of attention to detail and high-quality standards, maintaining data integrity
• Experience of working cross-functionally with project teams
• Excellent time management skills and ability to effectively manage changes to priorities and deadlines
• Experience in driving change and acting as a champion of change
• Experience in identifying and mitigating risks
• Strong leadership and influencing skillsPrevious experience in training and upskilling employees on GxP and SOPs

DESIRABLE:

• Life Sciences Degree or overseas equivalent
• MSc in Quality Management
• Experience in auditing in further GxPs (e.g., GMP/GLP/PVG/CSV)
• Experience hosting and responding to sponsor audits and/or regulatory inspections

WHY YOU SHOULD JOIN US: 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.