Our client is a leading manufacturer in the pharmaceutical industry. They are committed to maintaining the highest standards of quality in their manufacturing processes. They manufacture a range of medicinal products including liquid, semi solid and solid dosage products.They are looking to add QA Manager/Lead to their expanding team. You will work within a multi-disciplinary team to take a tactical role in the design, implementation, and establishment of suitable governance processes to assure the consistent GMP compliance of the GMP manufacturing facility. This is a full on site position in South Dublin.ResponsibilitiesPromote the awareness of quality requirements and support the evolution of the quality culture throughout the company and educate staff in quality related activities where appropriate.Maintain processes, including GMP document control (i.e. Batch review, issuance of document) and training, needed for successful site compliance to the PQS.Participate in the review performance of the PQS at planned intervals and provide regular reporting to ensure its continuing suitability, adequacy, and effectiveness and where appropriate, propose improvements.Participate in the execution of a GMP internal Audit/self-inspection programme, including identification and implementation of appropriate corrective actions and the process to track their completion via the change management system.Monitor and coordinate completion of GxP Audit PQS records (i.e., change controls, deviations and CAPAs) maintained within the QMS.Provide compliance support by providing advice and facilitating the escalation of compliance issues through the appropriate routes via the PQS.Work with other elements of the QMS and the QA team as required to support site compliance, business KPIs, and continuous improvements.Administration of the Quality Management System including allocation of document numbers, event numbers and maintenance of the associated logs.Ensure company compliance of Good Documentation Practices, maintenance of signature logs and company initials register.Notify document owners in a timely manner of pending SOPs/forms requiring review and track progress until completion.Responsible for issuance, obsolescence and archiving of the clients QMS documents.Creation, review and approval of Quality documents.RequirementsBSc or equivalent in scientific discipline.Understanding of GMPs and GDPs.Ability to manage multiple and varies tasks and prioritize workload with attention to detail.3+ years QA experience working within a GMP setting.Ability to apply risk-based approach for pragmatic problem solving.Strong organisational skills.Strong time management for the control of self-workload.Prior leadership experience and getting the best from the people around you would be highly beneficial.Flexible in supporting business needs.If this QA Manager/Lead job in South Dublin is of interest to you apply now or contact David Smith at Collins McNicholas Recruitment to learn more.
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