Quality Assurance Officer
ICDS Recruitment
Waterford
Quality Assurance Officer - County Waterford. Job Purpose: To support the Quality Assurance Manager with the development, implementation and maintenance of quality standards and systems to ensure that products comply with Marketing Authorisations, documentation, specifications and cGMPs. To develop compliance across the site. To ensure project plans and milestones are delivered according to agreed timelines. Responsibilities: 1. Compliance: To ensure that all work carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines. Ensure high quality output – vigilantly watch over job processes, tasks and work products to ensure freedom from errors, omissions or defects. Initiate action to correct quality problem and notify others of quality issues as appropriate. If a procedure does not exist, devise one, (through the appropriate channels); if a process needs amending, do so through the appropriate channels. 2. Continuous Improvement: To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement. Highlight opportunities for system optimisation to team members. 3. Documentation: To ensure review of all QC and production batch documentation when required and correctly in order to achieve a high level of customer service and cGMP. To ensure preparation of Submission Documentation in support of licence applications. 4. Leadership: Mentoring - support company with problem solving and skill development to aid learning and early problem resolution. 5. Vendor Management: Ensure that Vendor Management program is adhered to. 6. Technical Agreements: Ensure that customer/ Contract services Technical Agreements are initiated and maintained. 7. Customer requests: Ensure that all customer requests are dealt with within a reasonable timeframe. 8. Commercial Manufacture: Review batch documentation in a comprehensive and timely manor. Notify management of any anomalies which could impact the quality, safety of efficacy of a batch. 9. Self Inspection Program: Ensure Self Inspections are completed as per the defined schedule. 10. Inspections: Participate in outside Inspections (Customer audits / Regulatory inspections. 11. Vendor Auditing: Lead vendor audits of GxP services as required. Minimum Qualifications & Experience Sought: • Qualified to a minimum of degree level, preferably in a Science degree incorporating Quality Assurance. • At least four years’ experience working in a Quality Assurance role in a manufacturing environment. • Lead Auditor qualification an advantage. This job originally appeared on RecruitIreland.com.
2408 days ago