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Senior QA Specialist

Dublin, Dublin City
06/02/2019 (15:27)
Headcount Solutions Limited
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Quality Assurance Specialist Senior

We are seeking to recruit a Quality Assurance Specialist to become an active member of the quality team within a Dublin based biopharmaceutical multinational. The QA Specialist will be assigned to the IQA Quality functional area, which is responsible for the inspection and release of primary packaging components, in addition to the analysis of Defect Data from Incoming and Finished Product Inspection.

Key Responsibilities 
• Provide Subject Matter Expertise in relation to the testing of primary and packaging components for use in the manufacture of aseptic products. 
• Approve IQA Incoming test results. 
• Manage the introduction of new techniques and equipment to QA Incoming, including method transfers, and validations 
• Write protocols and perform validation and equipment qualification/verification. 
• Assume ownership and/or oversight of change control and NC/CAPA records; ensuring the scope of record is clear and implementation activities are robust and timely. 
• Compile and Analyse Metrics related to testing and disposition times for IQA 
• Analyse Defect Data from Incoming and Finished Product Inspection. 
• Generate Acceptance Sampling Plans to Justify acceptability of products. 
• Compile Technical Reports. 
• Write, review and approve Standard Operating Procedures in accordance with Amgen Policies. 
• Participate in customer complaint investigations with suppliers of components and packaging. 

Basic Qualifications 

• University degree. Engineering or Science related discipline preferred. 
• Relevant experience (8yrs +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role. 
Preferred Qualifications and Experience 
• Excellent written and verbal communication skills 
• Experience working with dynamic cross-functional teams and proven abilities in decision making 
• Project management or strong organizational skills, including ability to follow assignments through to completion 
• Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non Conformance /Deviation investigations 
• Detailed Knowledge of applicable Regulatory requirements. Experience with Regulatory inspections. 
• Experience working in aseptic operations, protein formulation, vial and syringe filling. 
• Use of Minitab, Excel and Smart Sheets

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