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Quality Assurance Officer

Reference:AJXV-854131 Location: Dublin
Qualification:DegreeExperience:4-5 Years
Job Type:Fixed Term ContractSalary: Not Disclosed

Quality Assurance Officer
Our Dublin based pharma client are currently recruiting for a Quality Assurance Officer. As Quality Assurance Officer, you will be responsible for supporting Quality Systems and ensuring GMP compliance across the site.

• Review all manufacturing and packaging batch documentation including electronic and paper batch records, for both pharmaceutical and medical device products
• Preparation of Annual Product Quality Review reports
• Effective management and control of the process deviation system, including timely preparation of deviation investigation reports
• Effective management and control of the change control system, ensuring all change controls are approved in a timely manner
• Co-ordination of investigations, reports and responses to customer complaints within the required timelines
• Review and approval of vendor files
• Liaising with suppliers to resolve supplier complaints
• Participation in internal audits
• Assisting in preparation for and participation in regulatory and customer audits
• CAPA management
• Participation in Risk Assessments / Root Cause Analysis etc
• Generation and reporting of Quality metrics monthly
• Participation in training initiatives including preparation and delivery of GMP training modules and any other training modules as required, for plant personnel
• GMP documentation preparation, review, approval and management
• Material Status Control activities
• Participation in GMP and Continuous Improvement projects within QA and on site
• Other duties as required and as directed by the Quality Assurance Manager

• A Bachelor's degree in a Science related discipline
• Knowledge of EU quality-related pharmaceutical regulations
• A minimum of 5 years’ experience of working in a similar Quality Assurance related role in the Pharmaceutical Industry
• Excellent written and verbal communication skills
• A high standard of report writing
• Strong attention to detail
• Excellent organisation skills
• Good IT skills
• Good decision-making skills
• The ability to be self-driven and capable of working on own initiative
• Proven capability of team participation
• Will be proactive and flexible

If you would like further Information you can contact the recruiter directly:

Sinead Cullen | Tel: +353 (0) 1 507 9252