Quality Assurance Officer- Waterford
Quality Assurance Officer- Waterford. The key purposes of this position would have the ideal candidate support the Quality Assurance Manager with the development, implementation and maintenance of the quality standards and systems in relation to packaging operations to ensure that products comply with Marketing Authorisations, documentation, specifications and cGMPs. Responsibilities: 1. To support the Quality Assurance Manager and Quality Assurance Team lead with the quality assurance function relating to packaging operations. 2. Electronic Documentation Management System - QUMAS. 3. To ensure that all work carried out in compliance with the required standards conforming to company, regulations. 4. Implement and maintain the Vendor Qualification Programme. 5. Review and approve batch related documentation as required. 6. Generation and approval of SOPs. 7. Internal and external QA audits. 8. Liaise with packaging operations / laboratory personnel to ensure regulatory and quality requirements are met. 9. Assist with preparation of Submission Documentation in support of license applications and customer requirements. 10. Noncompliance reporting and corrective action / continuous improvement implementation. 11. Operation of SAP Quality function as per procedures. 12. Support the on-going OOS/OOT/ Deviation/CAPA closeout programme. 13. To identify and make recommendations for improvements. 14. Check own work and that of others for accuracy. 15. To assist in the preparation for customer/ regulatory inspections. 16. Attend a number of cross functional team meetings as a Quality Assurance representative. 17. To perform additional team tasks as agreed to support effective running of the Business. 18. Compile and deliver quality based training with the company. 19. Health & Safety. 20. Implement safety requirements as per site documentation including SOPs, Safety Statement and COPs. 21. Report any Hazards. Minimum Qualifications & Experience. 1. A third level degree incorporating Quality Assurance/ management. 2. Ideally 3 years Quality Assurance experience in a pharmaceutical packaging environment. 3. Experience in packaging validation, Line clearance, Material reconciliation, packaging specifications, control of Artworks. 4. Experience in Serialization implementation and execution. 5. Experience in managing customer and supplier complaints. 6. Lead auditor training complete. 7. Internal audit experience. 8. Experience with facilitating customer audits. 9. Careful planning to achieve accurate and timely results to support the packaging plan. 10. Ability to define and manage own tasks and schedules. Other Information Reports directly to Quality Assurance Manager. Skills & Behavioural Competencies: Skills. 1. Multi-tasking, ability to achieve deadlines. 2. Strong compliance. 3. Computer Skills to include MS office. 4. Proven time management skills. 5. Planning & organizing. 6. Familiarity with cGMPs relating to pharmaceutical manufacturing. 7. Working knowledge of EDMS (Electronic Document Management System) and ERP (Enterprise Resource Planning. 8. Good attention to detail. Behaviours. Teamwork & Collaboration, Safety Awareness, Customer Focus, Quality Orientation, Problem Solving / Analysis, Innovation, Initiating Action, Adaptability, Project Management. This job originally appeared on RecruitIreland.com.
63 days ago