Senior QA Operations Specialist

  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 manufacturing processes as well as site modifications to allow the introduction of new products to the site

 

Role:
Supporting the Quality Operations and Systems team, the Senior QA Operations Specialist role will be primarily involved in supporting Quality Operations and Systems activities on site:

• All relevant activities on site are conducted in compliance with cGMP and client Standards
• Extensive experience in Quality Operations and Systems in Biopharma industry
• In depth knowledge of GMPs, GDDP and qualification/validation principles
• Extensive level of experience with reviewing and approving Investigations and ensuring RCA tools used and correct CAPA assignment.
• Ability to work independently and effectively in a fast-paced environment delivering to a high quality standard.
• Demonstrated knowledge of Quality Management Systems tools, continuous improvement methodologies and in-depth understanding of site processes.
• Strong technical aptitude (ability to read & comprehend technical documentation and execute procedures) and demonstrated experience interfacing with regulators is desirable.

 

If you relish the opportunity to work for a global leader in bio pharmaceuticals, please apply with your CV now.



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

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