Pharmaceutical Manufacturing Quality Engineer
Wigston
Up to £55,000 DOE
Summary
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 industry. SF are looking for a Quality Engineer to join our clients Quality Assurance department to act as the primary liaison with the engineering team. The individual will need a good foundation in engineering disciplines and will be provided training in the relevant pharmaceutical disciplines.
Job Description
- To provide technical, engineering review and input into the design, build and maintenance of equipment and facilities. This includes, but is not limited to:
o Providing QA review of User Requirement Specifications, Functional and Design Specifications, FAT and SAT.
o Assisting with creating Change Controls.
o Assisting with creating, and providing QA review, of calibration certificates generated in-house.
o 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).
o Providing QA review of engineering Standard Operating Procedures, ensuring the process is as described and suitable.
o 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 Devi...