Senior QA Specialist

I am currently working with a leading Biopharmaceutical company based in Dublin.

The client has recently opened a state of the art facility to sit next to their existing API Manufacturing facility.

The client is looking for a Senior QA Specialist to work closely with the QA Manager providing technical expertise on all QA activities and supporting other members of the team.

The successful Senior QA Specialist will have 5 years’ experience working within a quality function and will have worked within a Sterile or Aseptic environment.

• Management of review of Batch Manufacturing Records (BMRs).
• Management of the Change Control process, ensuring controlled implementation of all GMP related changes.
• Acting as a designee to the Quality Assurance Manager as required including motivation, training, discipline and appraisal of Quality Assurance staff.
• Implementing efficiency improvements in Quality Department on a continuous basis and participating in site projects and initiatives.
• Participation in the preparation of, and hosting, external cGMP audits, e.g. from Regulatory Authorities and Global Quality.
• Management of QA oversight of routine manufacturing, testing and relating activities to ensure ongoing cGMP compliance.
• Assisting in, and facilitating investigations as part of the site Deviation Management System, ensuring effective root cause analysis and assigning of appropriate CAPAs.

 
If you are local to Dublin and interested in discussing this position, please submit your profile and I will be in contact at my earliest convenience.



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

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