Exciting opportunity for an experienced Document Controller to join a highly ambitious cell therapy organisation based in Cambridge. Our client is looking for an experienced Quality document controller to join an expanding team to co-ordinate and manage all document control activities, ensuring compliance with the principles of data Integrity and all internal and relevant regulatory standards.
The initial aim of this role is to develop and implement processes for the control and management of the Quality Management System (QMS) documentation and assume responsibility for the issuance, tracking and control of Standard Operating Procedures, Master Batch Records, Test Records, forms, Protocols and Final Reports. There is a requirement to be diplomatic, collaborative, customer focused, change agile, comfortable in leading and adapting to changing priorities in a rapidly growing business.
This is a 6-month fixed term contract role that will convert to a permanent position, paying up to £35,000 plus an excellent benefits package. You will be based in the company’s modern site in Cambridge, though they have a very healthy approach towards the current Covid-19 guidelines and will accommodate you working 2-3 days a week from home (unless during HTA inspections, when you will be required on site 100%).
Your key responsibilities will include:
- Develop system and establish procedures for identification and numbering of document types.
- Create standard templates for QMS controlled documentation.
- Create, revise, and maintain company standard operating procedures (SOP’s) and other documents as required.
- Format, revise, track, and issue of controlled documents including SOP’s, protocols and other QMS documents as required.
- Manage and assist in the review of cGMP-controlled documents, as necessary.
- Issuance of batch production records, tracking of master batch records, tracking of all production records and lot number issuance.
- Maintain validation files (validation protocols, validation summary reports, engineering change controls).
- Interface with other departments regarding documentation requirements.
- Co-ordination and maintenance of quality system databases and logs.
- Initiate, complete and maintain change control documents.
- Provide administration support to the Head of Quality and QA Manager.
Your skills and experience will ideally include:
- Documentation Control within a cGMP environment.
- Good Manufacturing Practice within a Pharmaceutical or related environment.
- Good documentation Practice and principles of Data Integrity.
- Proficient use of Excel, Word and PowerPoint.
- Excellent time management, organisation, and communication skills.
- Experienced in working in a scientific / cell therapy environment.
- Experienced in Continual Improvement Tools e.g. LEAN, 5S, Kanban, Kaizen, RCA, VSM.
- QESH Management System / ISO9001 / PDCA Training.