Who we are
Newrotex is a start up based in Headington, Oxford using silk from spiders to create a medical device to repair large peripheral nerve injuries. We are a team of 7 meaning every member of the team is able to have a profound impact on the company as we enter the next phase of our development. Having completed our first in human clinical trials we are working towards market approval clinical studies in the US and the UK.
1. Purpose
The role of the Quality Assurance Officer (QA Officer) is to oversee the day to day running of the Quality Management System (QMS) and to support the Quality Assurance and Regulatory Affairs Manager (QA/RA Manager) in ensuring product quality, safety and performance (efficacy) are maintained via an effective QMS, in compliance with ISO 13485:2016, FDA 21 CFR Part 820, EU MDR and any other quality standards and regulations that are applied at Newrotex. The QA Officer will oversee the supplier management system, support with validation projects, provide quality control oversight in manufacturing and manage the documents and records which form the quality management system.
2. Duties and responsibilities
- Support an effective QMS by managing assessments of suppliers, updates to Approved Suppliers on the eQMS, Supplier Agreements, Performance Assessments and changes associated with suppliers.
- Manage, review and approve records within the QMS including but not limited to: nonconformance report, CAPA, change management, planned preventative maintenance, data analysis, and customer feedback. Ensuring that risk-based prioritisation is key and risks are mitigated via effective correction, corrective and preventive actions.
- Review and approve documentation updates for procedures, work instructions, forms and all other document types in accordance with good documentation practices. Administrate the documentation system either as a manual process or eDMS (in transition), ensuring current versions are available and superseded documents are removed from use and retained to current policy. Provide the current Word version of the documents to document authors for editing.
- Act as deputy for the QA/RA Manager regarding chairing design review and management review meetings. Record minutes and document KPIs on the status of the QMS. Report the status of the QMS to Top Management (COO/CEO) when requested.
- Support validation projects, including the execution of test scripts, the drafting of procedures and the conducting of training.
- Assist in managing the Greenlight Guru Clinical Trial Administration and training in accordance with internal procedures. Flag issues to the Sponsor team. Act as deputy for the QA/RA Manager regarding the steering committee for the clinical trial.
- Review batch manufacturing records against specification and provide an assessment of product disposition.
- Monitor employee training status. When procedural updates are made, ensure that appropriate training requirements are detailed.
- Update the eQMS and trackers with QMS actions and provide updates on the status of the actions.
- Organise product testing for endotoxin and crystallinity.
- Oversee pest control activities on site with the approved vendor.
- Provide QA support to manufacturing to ensure that documentation and procedures are followed and facility monitoring is appropriately performed.
- Conduct internal audits and support in audits of suppliers as required. Support in preparation and hosting of third-party audits.
- Support with updates of the documentation which forms the Design History File for the product.
- Support with Risk Management activities at Newrotex related to the product, process and QMS.
- Act as document owner and/or subject matter expert for specific procedures and processes within the QMS.
- Proactively organise workload to ensure that business requirements are met.
- Provide regular feedback to the QA/RA Manager and/or COO.
- Provide support cover for spider husbandry activities on an ad hoc basis.
3. Qualifications
Qualifications shall include:
- Education – Degree level qualification in a Life Science (such as Biology, Chemistry, Biomedical, Biotechnology, Bioengineering).
- Experience in working to GxP in the medical device industry or other similar a controlled industries incorporating SOPs, aseptic technique, environmental monitoring, risk analysis, ISO standards and internal auditing.
- Skills & Attributes – Prioritise critical product impacting risks, capable of impact assessing nonconformances for the implications to GMP conformance, product quality, patient safety and product efficacy.
- Abilities – Can organise own workload and prioritise conflicting demands.
- Other characteristics such as personal characteristics - Self-motivated, organised, good communicator decisive and able to assess information in a pragmatic manner.
Desirable:
- Certification demonstrating ISO 13485:2016 awareness
- Professional Certification for internal or external auditor
Working Conditions
Full-time 37.5h pw. Office based. May work remotely occasionally with prior approval from Line Manager.
Pay: £31,000.00 per year
Work Location: In person
