Address
Salary ABOUT US:
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:
DESIRABLE:
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 GMP Quality Assurance Officer to join our IMP Management Department where you will be responsible for providing GMP Quality Assurance activities within the IMP Management department. You will work with qualified persons, the production team, and the wider company Quality Assurance department to ensure patient safety, data integrity, and regulatory compliance in manufacturing medicines for clinical trials.
KEY ACCOUNTABILITIES: - Perform QA review of finished Investigational Medicinal Products (IMP), including batch documentation reviews and visual inspection.
- Compile and review documents for study Product Specification Files.
- Draft and maintain GMP Quality documents, including Technical Agreements, QP to QP Agreements, study GMP Risk Assessments, Site Master File and MIA(IMP) documents.
- Control, issue, and distribute controlled documents, e.g. batch records and labels.
- Work within and support the continuous improvement of the QMS, including writing/reviewing/approving SOPs, master templates, change controls, deviations, and CAPA (Corrective and Preventive actions).
- Identify opportunities for quality and process improvement and lead on implementation.
- Track, trend and evaluate department quality issues, e.g., deviations and non-compliances, CAPA, change controls, and manage periodic GMP Pharmaceutical Quality System reviews.
- Review and approve incoming materials, equipment service reports, environmental monitoring reports, and media fill simulation results.
- Maintain equipment calibration list.
- Prepare for and support Regulatory Inspections and Sponsor Audits, including responding to GMP questionnaires and audit reports.
- Manage the GMP provider qualification process, including conducting supplier and subcontractor approval assessments, document reviews and audits.
- Support QPs in dealing with IMP complaints and recalls.
- Act as departmental Training Contributor, liaising with the Learning and Development team.
- Maintain awareness and knowledge of current developments in relevant GxPs, regulatory requirements/expectations and industry trends.
ESSENTIAL:
- Experience working in a QA/Quality Management role within a GXP regulatory environment
- Experience in addressing deviations / non-compliances, including Root Cause Analysis, Corrective and Preventive Action
- Experience in dealing with inspections and audits
- Experience in working cross-functionally with project teams to plan and overcome challenges
- High level of attention to detail and high-quality standards, maintaining data integrity
- Excellent time management skills and ability to effectively manage changes to priorities and deadlines
- Work efficiently and independently in a fast-paced environment
- Excellent verbal and written communication, fluent in English
DESIRABLE:
- Experience within a Clinical Trial environment or pharmaceutical company
- Experience or solid understanding of IMP assembly/production
- Experience or good understanding of aseptic processing
- Experience in analytical QC and/or Microbiology QC
- Experience hosting and responding to sponsor audits and/or regulatory inspection
- Experience in auditing to GxP quality standards
- Experience in training colleagues on GXP and SOPs
- Degree in Science Subject or equivalent
- MSc in Quality Management or similar
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.
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.
