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Rachel Kent
Life Science

+353 87 427 8808
[email protected]
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Details

Senior Associate Quality Assurance


Reference:RK2405 Location: Dublin
Qualification:DegreeExperience:3-4 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: QA Specialist

Senior Associate Quality Assurance
RK2405
12 Months
Dublin


We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.


Duties:

• Testing of primary and secondary components for use in the manufacture of aseptic products.
• Sampling of Excipients and Drug Substance under Grade C conditions.
• Review/approve documentation associated with component testing in preparation for QA Specialist or Qualified Person disposition activities
• Compiling, Review and approval of minor NC and CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable
• Provide training and advice to staff in relation to testing of components and packaging.
• Actively participate in audits and their preparation.
• Review cGMP records (e.g., WO, JP, GDMS, NC, CAPA, protocols, reports, SOP, etc.) ensuring compliance with appropriate documentation
• Write, review and approve Standard Operating Procedures in accordance with company Policies.
• Perform all activities in compliance with safety standards and SOPs
• Support continuous improvement and Operational Excellence initiatives
• Any other tasks/projects assigned as per manager’s request.


Education and Experience :

• Bachelor’s degree in a Engineering or Science related discipline preferred.
• 4 years experience working in the pharmaceutical or biotechnology industry
• Experience in managing Root Cause Analysis / Non-Conformance /Deviation investigations


If interested in this posting please feel free to contact Rachel Kent on +353 (0)87 427 8808 or [email protected] for further information.