Senior Quality Risk Assessor

Senior QA specialist required by a leading biotechnology company to support the introduction of New products and Quality Systems into a biotechnology  facility in Dublin, Ireland.

 
Working on this state of the art, newly acquired facility, the successful candidate will be responsible for integration our clients internal quality systems and Risk Strategy for manufacturing processes as well as site modifications to allow the introduction of new products to the site.

 Supporting the Quality Systems team  the Quality Risk Management (QRM) Assessor role will be primarily involved in developing and managing the Quality Risk Management Program to ensure all the Regulatory required  Quality Risk assessments are completed.

• Facilitation of  Quality risk Assessments
• Implement  Risk management Principles, methods and tools in line with client Standards
• Facilitate and coach for root cause analysis in the required areas.
• Schedule and lead risk assessments  to identity risk,  implement risk mitigation's measures and manage in the client  RMS.
• Partner with Global QRM stakeholders and represent on site.
• In depth knowledge of GMPs and GDP principles

Desired experience 

•   Ability to work independently and effectively in a fast-paced environment delivering to a high quality standard.
• Extensive level of experience with performing risk assessments using different tools (e.g. FMEA, FTA, HACCP, etc
• Individual will be versed in risk management tools and RCA
• Minimum of 5 years’ experience in QRM in a Bahamaceutical or biologics or pharmaceutical setting. 

Please apply now for this long term contract opportunity. 





The candidate must have the rights to work in the location stated in the job advert.

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