We are looking for a QC Compliance Specialist who will report directly to the QC Compliance Manager and who will liaise with cross functional teams on site, in particular QC Operations, Automation Compliance, Regulatory, Tech Eng and Commissioning and Qualification teams to ensure regulatory requirements are met. The role will support all laboratory documents including protocols / reports SOPs / deviations / investigations / trend reports.
• The successful specialist will provide technical expertise, trouble-shooting, training and support to the incoming quality team and in addition, will liase with technical subject matter experts from other sites as well as participate in above site analytical and technical forums.
• Provide quality support for the Quality Operations Laboratory.
• Acts as Quality point of contact for the QC Compliance Manager as required.
• Provide technical support and apply expertise and critical thinking to help to resolve technical and compliance issues.
• Assist in the review of accurate lab operational procedures, training materials and procedures for various systems.
• Facilitate the daily team meeting and ensure team representation at required cross functional forums.
• Participate in the review and update of SOP’s, trend data, investigations, non-conformances, validation protocols, reports, method validation/verifications and equipment qualifications.
• Assist in the review of data for periodic reviews as required.
• Drive continuous improvement, perform root cause analysis on system failures and substandard equipment performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc, all under aseptic/clean room conditions. Provide input, review and approval for atypical, observation, and process capability investigations. Oversee coordination of resources to implement suggestions/ideas of merit. On assignment, and depending on experience, participate in or lead departmental initiatives on improved compliance and quality systems.
• Contribute to the achievements of department productivity and quality goals.
• Provide support with audit/inspection requirements to ensure department compliance/readiness.
• Participate in internal and external audits and inspections, taking the role of auditee / auditor for assigned areas of responsibility.
• Liase with site CoE (Centre of Excellence) for regulatory and compliance matters.
• Bachelors Degree or higher preferred; ideally in a related Science discipline
• 5 – 8 years’ experience in a quality role (QC/ QA), ideally in a pharmaceutical manufacturing environments.
• Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
• Knowledge of cGMP and GDP preferred.
• Report, standards, policy writing skills required.
• Equipment and process validation.
• Sterile filling processes and equipment.
• Proficiency in Microsoft Office and job related computer applications required.
• Lean Six Sigma Methodology experience desired.
• Ability to work as part of a team to determine priorities.
• Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance.
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