Role: Process Scientist / QA
Salary: Competitive, plus additional bonus
Hours: Days - Monday/ Friday
Our Client, a major - Global Medical Devices company are looking to recruit for an experienced Products Transfer Scientist, who will work at their modern; European Hub based in Manchester with manufacturing and R&D innovation onsite. This person will play a key part of development and the transfer or product applications and technology; they will play also be involved in the full life cycle of the product, leading to significant training and development within production and quality.
- Supports and sometimes leads in the efforts to scale up, optimize, validate and transfer bulk, fill and lyophilization processes to production.
- Management of project plans and timelines, with use of Microsoft Project and ability to highlight and problem solve issues during project completion.
- Lead project meetings, with a clear agenda and meeting minutes.
- Assists in the development of manufacturing processes for transfer to Manufacturing
- Authoring of project documentation, for instance Validation Protocols, Master Validation Plans (MVPs), Quality Plans (QPLs) and Master Validation Reports (MVRs).
- Trains others on newly developed procedures
- Independently produces notebook, pilot and production materials
- Keeps accurate records and documentation
- Extensive understanding of working within a quality management system that conforms to the ISO13485 standards, including authoring SOPs and Manufacturing instructions when required and/or Support the Technical Writers by contributing to manufacturing work instructions, area guidelines, knowledge base topics, style guides/templates, & department SOPs
- Will hold a Degree in a relevant Scientific discipline
- Will have experience in Validation/ GMP based
- Will have experience in CAPA's and root cause investigation/ problem solving within the QA process
- Will have experience in a meeting setting/ commercial setting , be able to contribute effectively in a meeting and be able to project manage tasks independently
- Strong interpersonal skills, with the potential to progress with the company.
- Good analytical skills
- Will have worked through the whole product lifecycle process; and have experience in technical transfer project management
- Will have worked to 13485 based standards