Temp Quality Technician (Medical, Pharma)
Temp Quality Technician (Medical, Pharma) Cardiff to £16 p/h 4 Months Our client specialises in the design, development, manufacture and marketing of surgical devices for use in advanced minimal access and outpatient surgical procedures.Based in purpose built premises in South Wales it is the UK centre for R&D, they now have an immediate requirement for a Quality Systems Assistant ref – C/QSA/SW02 to provide such support as becomes necessary to facilitate the orderly operation of the QS Department. ESSENTIAL DUTIES AND 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. EDUCATION: · HNC level with an emphasis on either a science or engineering bias, however proven experience in a similar role will be considered. ESSENTIAL KNOWLEDGE, SKILLS AND ABILITIES: Work experience · Minimum of 1 year experience working in a QA/QS environment within the medical device or pharmaceutical industry. Knowledge · Knowledge of ISO13485:2003 and Medical Device Directive MDD 93/42/EEC · Knowledge of FDA QSR Part 820 Skills · Computer literate to include MS Word, Excel and MRP · Ability to communicate well in English both written and orally Behavioural Competencies · Good inter-personal skills
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