Amgen Sr Associate QA (Shift) in Dublin, Ireland
Plant QA Snr Associate (Inspection & Packaging)
The Plant Quality Assurance (PQA) Snr Associate will typically report to a QA Manager or Senior Manager and is a core member of the site Quality Assurance team. The PQA Snr Associate will serve as Quality point of contact for manufacturing operations.
The site is focused on continuous improvement of all work processes and practices, therefore in addition to routine Quality Assurance duties, PQA Snr Associates may be asked to carry out additional work functions to support site continuous improvement activities.
• Perform all activities in compliance with Amgen safety standards and SOPs
• Write, review and approve Standard Operating Procedures in accordance with Amgen Policies.
• Provide Quality support for triage and investigation of all classes of non-conformance (NC) events
• Review and approval of NC1s and CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable
• Participates in customer complaint investigations.
• Provides training and advice to staff in order for them to perform their desired functions.
• Observe and provide real-time quality oversight, and support for production unit operations
• Perform Visual Inspection AQL inspections and provide quality oversight for the inspection program
• Review/approve production batch records, and associated documentation in preparation for Qualified Person disposition activities.
• Review and approve cGMP records (e.g., NC, CAPA, protocols, reports, SOP, etc.) ensuring compliance with appropriate documentation
• Support continuous improvement and Operational Excellence initiatives
• Any other tasks/projects assigned as per manager’s request.
Basic Qualifications & Experience:
• University degree. Engineering or Science related discipline preferred.
• Relevant experience (4 yrs +) 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 & Experience:
• Excellent written and verbal communication skills
• Experience working with dynamic cross-functional teams and proven abilities in decision making
• 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
• Experience working in Pharmaceutical industry, specifically VI and packaging operations
• Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues
• Operational Excellence experience