Description
A major pharmaceutical organisation based in Ireland requires an experienced QA Specilist to join the team. The QA Specialist will carry out duties within the experienced Quality team.The Role:
*Provide quality oversight and expertise as required for manufacturing operations.
*Review of all manufacturing batch documentation including electronic batch records, real time reports and 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.
*Facilitate compliance direction for the site by assisting in the adherence to divisional policies and guidelines as well as regulatory requirements.
*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
*Working as directed by QA Lead according to Company safety policies, cGMP and cGLP
Qualification/Experience:
*Bachelors Degree
*3 years experience working within a manufacturing facility (IMB and FDA approved)
*Expertise in Aseptic Assurance and Process Simulations.
*Experience in batch review, electronic batch record.
*Previous use of SAP/Trackwise.
*A proven track record of effectively working with a manufacturing operations team to ensure best practices are implemented and improved.
An excellent hourly rate is on offer alongside a long term contract opportunity.
Please apply today with a covering letter highlighting your key skills and relevant experience aligned to this contract opportunity.