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QA Specialist II

€Generous + benefits | Ireland |  QA |  Permanent  | Ref:888387



Nadya Libecans

Which team do you work in? 

Drug Development

Which area do you specialise in?

Quality Control and Assurance

How do you keep up-to-date with the latest news in your sector?

I frequently read articles on changes and happenings in the industry, stay well connected on LinkedIn and regularly check in with relevant industry professionals.

What's your favourite film and why?

Honestly, I watch so many films it's difficult to pick just one, so for today I'm going to go with Mermaids because you can't go wrong with Cher!

If you could invent one thing what would it be?

Definitely would have to be heels that turn into flats so that I wouldn't have to carry two pairs of shoes everywhere anymore

What makes you #DistinctlyDifferent?

I believe knowledge is power and I strive to learn as much about people and the industry as possible to build lasting relationships and produce the best results for candidates and clients. 


The Role

QA Specialist II - CRO - Dublin - €Generous benefits


The Company

Our client is a leading Global Clinical Research Organisation specialising in drug, diagnostics and medical devices development.

  • Are the world's second largest provider of late phase services.

  • Have an excellent reputation in the Pharmaceutical industry for a range of therapies including Oncology and Genomics.

  • Have obtained a number of high profile awards for their work.


The Role

Our client is looking for a highly skilled Senior QA Specialist to assess and support the quality practices surrounding the computer system life cycle along with conducting audits to ensure compliance standards are consistently adhered to.

  • Assist Development Team in QMS, regulatory compliance and the sustaining process of new products and features.

  • Lead on Quality investigations, CAPA's, deviations and customer complaints.

  • Conduct root cause analysis and report on audit findings.

  • Develop appropriate Quality checkpoints in the NPI process feeding into the SDLC to ensure efficient and effective compliance strategies



Our client is looking for a candidate with the ability to lead on projects and engage with the QA and Technology teams as well as management, stakeholders and regulatory bodies.

  • Qualification in Life Sciences, IT or Technology (or equivalent) at Degree or Diploma level or relevant work experience.

  • IT Validation experience in the Pharmaceuticals, Medical Devices, Technology or Finance sectors

  • Understanding of cGXP regulations is desirable

  • Clear understanding of SDLA methodology in line with Computer System Validation (CSV)

  • Occasional travel is required so a clean full driving license is desirable


What should you do next?

This Senior QA Specialist role is one not to be missed; it encompasses the opportunity to lead on exciting projects across a number of therapies…….. To discuss further, please submit your current CV.

Unless otherwise stated, if applying for a job within the European Union, you must ensure that you are already authorised to work there. Carrot Pharma Recruitment Ltd acts as an Employment Business and an Employment Agency on behalf of our client in recruitment for this role.