Quality Assurance Specialist

Carlow  ‐ Onsite
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Keywords

Description

A multi-national pharmaceutical company based in Carlow is looking to recruit 2 Quality Assurance Specialists on a 12 month contract basis.

Candidates should have aseptic processing/ manufacturing and/or batch review experience.

The QA Specialist shall carry out most of his/her duties in the Quality IPT Function and the primary tasks and responsibilities of the position are as follows.

- Review of all manufacturing batch documentation including electronic batch records, real time reports, master data.
- Responsible for supporting deviation and atypical close out and initiating/following up on corrective and preventative actions using the site SAP system as a tool.
- Assist in the proactive evaluation of site compliance against emerging regulatory trends.
- Drive continuous improvement by leading and active participation in system failure investigations and investigation reports, execution/development of change control, and contribution to Kaizen events as appropriate.
- Review and approval of validation documents, change controls, SOP's for the IPT department
- Leading out of specification investigation
- Working as directed by QA Lead-IPT according to Company safety policies, cGMP and cGLP

Requirements:
- Bachelors Degree or higher preferred; ideally in a related Science discipline
- At least 3 years experience working within a manufacturing facility (IMB and FDA approved)
- Expertise in Aseptic Assurance and Process Simulations will be an advantage.
- Experience in batch review, electronic batch record would be an advantage.
- Previous use of SAP/Trackwise would be beneficial.
- Ability to critically review analytical data. Possessing excellent attention to detail is a must.
- Ability to trouble shoot, identify microbiological issues and follow up with corrective actions.

If you would like to hear more about the role and company please contact me Anna Mooney or apply below with an up to date CV.
Start date
07/2014
Duration
12 Months
From
Real Staffing
Published at
24.06.2014
Project ID:
730362
Contract type
Freelance
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