Document Technician – Temporary – 6 month contract to start
£12 - £13.50 per hour
Prestigious Loughborough based pharmaceutical client is seeking a candidate to support the Manufacturing department and Supply Chain. This role will include updating product specifications, Manufacturing batch records, Product Quality Reports and other relevant documents. It requires the co-ordination of updates to multiple documents, ensuring accuracy and consistency for audit, and using MS Word and a bespoke document system.
We are seeking candidates who:
- Have experience in Document writing, which may be the writing of SOP’s or similar. This would need to be in Pharmaceutical, Aerospace or Food industries.
- Must be fully computer literate using Word and Excel. Experience using bespoke programs would also be beneficial.
- Will understand the stringent requirements of working in a regulated environment.
In addition, the following attributes will be highly beneficial:
- Knowledge and application of current safety regulations and requirements.
- Actively raise and support the resolution of APR’s, NM and MI’s.
- Complete Risk Assessments as required.
- Effective Root Cause analysis for unplanned deviations using appropriate methodologies and site systems.
- Have working knowledge of site documentation and change control systems and be able to prepare detailed and effective Change Control documentation.
- Be able to author product specifications, batch records, validation documents and associated reports, as well as any other specific technical documents as required.
Candidate will ideally have an awareness of current regulatory standards e.g. Eurdralex/Orange Guide and ISO standards for medical and sterile devices, and an understanding of manufacturing processes, and an awareness of lab testing and key quality attributes, and their impact on the products.
The successful candidate will be educated to degree level or have equivalent experience in a relevant science/engineering discipline. It would be desirable to have worked with a GLP, GMP, or ISO accredited organisation.
This role is initially a 6 month temporary assignment, with the strong possibility of it being extended.