Description
Compliance Engineer - Contract - Loughborough - to £33000
There is an opening for a Compliance Engineer in Plant Engineering to work for this world famous and innovative manufacturing company. It is a 12 month contract to cover maternity leave.
*Your responsibilities include ensuring that GMP/EHS regulatory compliance is met by the Plant Engineering Group with respect to its associated areas of responsibility (ie facilities, utilities and equipment)
*You'll be creating and maintaining regulatory documents and the control of associated processes and procedures.
*Ensuring compliance with Change control (CMR and ECC) and the creation, update, submission and Maintenance of related documents.
*Coordination and supervision of GMP service providing contractors, including the collation, checking and filing of all of the GMP data that they produce. (eg Verification of NVP data and ensuring it is correctly entered on Env.DB, Ensure CAPP data is within spec of BODs, and ensure QIRs are raised if necessary, NVP for compressed gases etc). Ensuring documented compliance control of associated Contractor GMP processes.
*Regulatory, customer and internal audit support, including collating and presenting drawings, documents and data.
*Raise and complete QIRs, CAPAs (eMatrix and SAP) and all associated documents on behalf of the Department
*Collating and reporting Plant Engineering Compliance Data to daily Tier 2 meeting and Monthly QA Review.
You will ideally have:
*A recognised Engineering/Technical Qualification with previous experience of working in a GMP regulated industry including experience within a Quality role
*Knowledge: GMP related regulations, Environmental, Health & Safety standards
*You'll have excellent interpersonal & team working skills,
*Able to develop documentation or recording systems,
*Highly PC literate (MS Office, Enovia and SAP).
*Excellent collation and interpretation of detailed data