Hours: Days - Monday to Friday
Salary: Competitive DOE
Additional: Parking onsite, private medical, life assurance, company pension, attendance bonus
Our Client, a leading Diagnostic / Medical Devices company - is expanding and looking to recruit for 3 Scientists across different departments in their QC and R&D teams. Our client is looking for individuals with strong microbiology testing/cell culturing experience in a regulated environment (ISO 17025/ 13485, NHS hospitals)
- Using specialised technical knowledge and skills to work on the development, documentation and evaluation of new products.
- Performing investigations related to the improvement of existing products and to investigate resolution of manufacturing issues.
- To apply a good understanding of QA, GMP, IVD Directive (IVDD) and Regulation (IVDR), ISO 9001 and ISO 13485 guidelines to products, allowing them to meet regulatory and market requirements and to generate significant profit for the company over their lifecycle.
Summary of Role and Role Objectives:
- Responsible for carrying out existing and new product development activities as agreed under the general supervision of the line manager. All activities are to be conducted to the agreed scientific and regulatory standard or directives e.g. European IVDD and IVDR of the department and promptly reporting deviations from stated targets of performance.
- To be responsible, with minimum supervision, for conducting reviews of literature related to investigations being undertaken, conducting and, where necessary, enhancing experimental design, carrying out research studies, analysis of experimental data, reporting of studies in the form of a written report as per laboratory standards and ensuring raw materials are available as required for investigative studies.
- To ensure products are designed and manufactured with sufficient robustness, so they do not compromise the health and safety of patients, users and third parties and attain the performance levels specified by the manufacturer.
- To be responsible for ensuring all activities are carried out in accordance with Company design policies.
- Supporting senior staff to provide a high standard of technical service and support including the investigation of customer complaints, production problems and assistance with validation studies.
- To be responsible for the collation of reference information relevant to all investigations and for the correct maintenance and updating of technical records in appropriate project files for allocated projects.
- To participate in laboratory project meetings where technical matters affecting current projects and present results are discussed.
- To provide assistance to senior staff in technical training for Sales and Marketing and laboratory personnel.
- To provide cover for Quality Control staff, as agreed between the Quality Control and R&D Managers when necessary.
- Prepare and present written reports and documents as directed, including the preparation and updating of Standard Operating Procedures, technical dossiers demonstrating product compliance with regulatory standards or directives, reports and documents for company policy and other meetings. Such reports should usually be presented in an appropriate electronic format (e.g. Microsoft Word).
- Will hold a Degree in a Life Sciences or Biomedical discipline.
- Will have QC/ Lab /Science experience working to ISO 17025 in an GLP/GMP setting and ideally (not essential) a Medical Devices 13485 setting. Pharmaceutical, Biotech/ Lifesciences, Personal Care and NHS Hospital experience will also be considered.
- Strong knowledge in micro testing (cell culturing etc)
- Strong report writing skills.
- Will have a good understanding/appreciation of quality / working to above QMS.
- Advanced IT knowledge (Excel, LIMS etc).