Catalyx (formerly Crest Solutions) are seeking a QA Specialist to work fully onsite in the Packaging department on our customer site in Cork. The QA Specialist is responsible for the creation, revision and delivery of GMP documentation to our FDA regulated customer.

Responsibilities and Tasks:

• Provide Quality Assurance services to the Packaging Department
• Review and approval of GxP documentation
• Batch Record Review and Batch Disposition
• Updates Quality assurance SOPs as appropriate
• Scans and archive documentation as required
• Finished Product Inspection
• Performs Deviation Investigations and Root Cause Analysis
• Customer Complaint Report Generation
• Line Clearance of Packaging Areas
• Recommends process improvements and proposed changes
• Provides supports with internal and regulatory audits/ inspections as required
• Support training and mentoring of new starts
• Provides additional support and assistance on tasks and projects as directed by management
• Work with cross functional teams
• Deliver on agreed KPIs and metrics
• Other duties as required

Skills and Experience:

• A relevant third level qualification in a QA discipline
• 5 years’ relevant industrial experience in the pharmaceutical industry
• Demonstrable knowledge of Document Control fundamentals, Quality Systems and GMP requirements.
• Established general knowledge of the processes and impact of document control, and relationship between the document change process and products
• Understanding of the current pharmaceutical industry and applicable regulations including 21 CFR, GxP, ICH etc
• Working knowledge of Electronic Document Management Systems (EDMS)
• Keeps abreast of the requirements for compliance in own work area
• Demonstrate problem solving skills with proven attention to detail
• Proficiency in Microsoft Office applications and Oracle environment
• Excellent written and spoken communication skills with established interpersonal skills
• A can-do attitude towards customer delivery and performance

Why Join Catalyx?

At Catalyx we understand that our people are our greatest asset. For this reason and many others, we take care of them. The team in Catalyx benefits from a Total Rewards package. This includes great personal benefits and professional growth opportunities. An example of what is offered to our team members is as follows:

• Competitive salary.
• Full healthcare cover, leave benefits, life assurance, flexi-time and pension scheme.
• A varied and exciting career with Catalyx with opportunities to work in a cutting-edge, innovative technological environment.
• A structured approach to professional development opportunities with an educational assistance program