CV-Library
This is a unique opportunity for a Quality Engineer to transfer their skillset from more conventional industries, such as Automotive and Aerospace, into an equally regulated pharmaceutical industry.
Our client is expanding rapidly and has a small in-house team of design engineers, machinist and welder, control engineers, service engineers and building systems and maintenance engineers. They are looking for a Quality Engineer to join their Quality Assurance department to act as the primary liaison with the engineering team.
You will need a good foundation in engineering disciplines and will be provided training in the relevant pharmaceutical disciplines.
Key responsibilities
* To provide technical, engineering review and input into the design, build and maintenance of equipment and facilities. This includes, but is not limited to:
* Providing QA review of User Requirement Specifications, Functional and Design Specifications, FAT and SAT.
* Assisting with creating Change Controls.
* Assisting with creating, and providing QA review, of calibration certificates generated in-house.
* Creating User Requirement Specifications for the engineering team when the driver is improvement in quality (e.g. to accommodate a change in the pharmaceutical regulations).
* Providing QA review of engineering Standard Operating Procedures, ensuring the process is as described and suitable.
* Providing QA Go/No Go decisions for engineering.
* To run CAPA clinics for the engineering team to help the team close out overdue actions on QIs and Deviations and help generate and keep updated progress on planned Change Controls.
* To provide Subject Matter Expertise in investigations that requires engineering knowledge, collate supporting information from the engineering team and complete Risk Assessments on the impact of engineering QIs and Deviations.
* To provide technical, engineering review and input to the Validation Team during IQ/OQ.
Experience & Qualifications
* MEng in Mechanical, Automotive, Aerospace, or similar. The role requires a broad foundation in understanding of basic engineering disciplines:
* Materials and Structures.
* Pressure and Flow.
* Heat Transfer.
* Mechanisms and Control.
* Specialism in material identification and fractography preferable.
* Industrial experience as a Quality Engineer and experience with Quality Management Systems.
To apply for this job please visit www.cv-library.co.uk.