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Senior QA Specialist

Job Field:
Regulatory and Drug Safety Jobs
Discipline:
QA Jobs
Country:
Ireland
Region:
Cavan
Contract Type:
Permanent
Currency:
£
Salary:
50,000 to 65,000 per annum
Posted:
22-Jan-19
Recruiter:
Carrot Pharma
Job Ref:
888001

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.
* Manage the internal and external audit schedules and mentor QA auditors on process and service improvement.
* Develop appropriate Quality checkpoints in the NPI process feeding into the SDLC to ensure efficient and effective compliance strategies

You

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 (or equivalent) at Degree or Diploma level or relevant work experience.
* QA experience in the Pharmaceuticals, Biotech or CRO sectors.
* Working knowledge of cGxP including GMP, GCP & GLP to MHRA and FDA standards.
* 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.

Closing Date:
19/02/2019

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