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.
The Quality Assurance (QA) Snr Associate will typically report to a Snr QA Manager and is a core member of the site Quality Assurance team. The QA Snr Associate will serve as Quality point of contact for Packaging operations, as well as support the complaints function.
• Perform all activities in compliance with safety standards and SOPs
• Observe and provide real-time Quality oversight and support for Packaging unit operations.
• Participates in Customer complaint investigations.
• Perform Packaging check audits.
• Provide Quality support for triage and investigation of all classes of deviation events
• Review and approval of Deviations and CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable
• Review/approve production batch records, and associated documentation in preparation for Qualified Person disposition activities.
• Provides training and advice to staff in order for them to perform their desired functions.
• Write, review and approve Standard Operating Procedures in accordance with policies.
• Support continuous improvement and Operational Excellence initiatives
• Any other tasks/projects assigned as per manager’s request.
Education & 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.
• 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 / Deviation investigations
• Experience working with combination products or devices in packaging-related or complaint-handling activities
• Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues
• Operational Excellence experience