Quality Systems Assistant (Contract)

Key Requirements

*Minimum of 1 year experience working in a QA/QS environment within the medical device or pharmaceutical industry.
*Knowledge of ISO13485:2003 and Medical Device Directive MDD 93/42/EEC standards and regulations
*Computer literate to include MS Word, Excel and MRP
*Ability to communicate well in English both written and orally
*Good inter-personal skills

Key Responsibilities

*Assist in Document Control including change control management and archive control.
*Provide support for progression of NCRs, CAPAs and complaints.
*Provide support for progression of the internal audit program and follow-up actions.
*Liaising with Operations and relevant departments for all of the above.
*Provide support for the generation of required quality, KPI and departmental metrics.
*Prioritisation of work to meet daily business requirements and timelines.
*Proactively support Improvement initiatives.
*Ensures timeliness of activities for progression and closure.
*To ensure regulatory compliance to both European and US standards of Good Manufacturing Practice.
*To adhere to the standards of behaviours, policies and procedures as laid out in the Contractors Guide.
*All other essential related duties as required.