**Quality Assurance Expert

2 weeks ago

Cork, Cork, Ireland beBeeQuality Full time €40,000 - €60,000

**Job Description**

Catalyx is seeking a skilled Quality Assurance Specialist to join our team and work on-site with customers. The specialist will be responsible for creating, revising, and delivering GMP documentation to FDA-regulated customers.

**Who We Are**

Catalyx specializes in the science of operational processes. With a global presence across North America and Europe, the company carefully automates and services R&D, production, packaging, and delivery processes – globally – with a sophisticated blend of products, technologies, and lifecycle services. Our partnership-based culture has helped organizations optimize their operational efficiency, performance, and safety for over three decades.

**The Role**

As part of our commitment to innovation and excellence, we are continuously developing our on-site teams to support the advancement of customer operations. This role involves delivering quality assurance support to the packaging department, evaluating and approving GxP documentation, conducting batch record reviews, and updating standard operating procedures as necessary.

**Responsibilities**

  • Deliver quality assurance support to the packaging department
  • Evaluate and approve GxP documentation
  • Conduct batch record reviews and disposition processes
  • Update quality assurance standard operating procedures (SOPs) as necessary
  • Scan and archive documents as needed
  • Inspect finished products
  • Investigate deviations and conduct root cause analysis
  • Generate reports for customer complaints
  • Clear lines for packaging areas
  • Suggest process enhancements and recommend changes
  • Assist with internal and regulatory audits/inspections as required
  • Support the training and mentoring of new employees
  • Provide additional support and assistance on tasks and projects as directed by management
  • Collaborate with cross-functional teams
  • Achieve agreed-upon KPIs and metrics

**Required Skills and Qualifications**

  • Relevant third-level qualification in a QA discipline
  • Minimum of 2-3 years of relevant industrial experience in a QA role, preferably in the pharmaceutical sector
  • Experience with batch record review in pharma/Med devices essential
  • Demonstrable understanding of document control principles, quality systems, and GMP requirements
  • Comprehensive knowledge of document control processes and the relationship between document change processes and products
  • Familiarity with current pharmaceutical industry and relevant regulations, including 21 CFR, GxP, and ICH guidelines
  • Proficiency with electronic document management systems (EDMS)
  • Stay informed about compliance requirements in your work area
  • Exhibit strong problem-solving skills with attention to detail
  • Proficiency in Microsoft Office applications and experience with Oracle
  • Excellent written and verbal communication skills, coupled with strong interpersonal skills
  • Proactive attitude toward customer service and performance

**Benefits**

We understand that our people are our greatest asset, and we take care of them. Our total rewards package includes great personal benefits and professional growth opportunities. Catalyx is an equal opportunity employer committed to creating a diverse and inclusive workplace where all individuals are valued, respected, and supported.

**Why Choose Us?**

At Catalyx, we are committed to attracting the best global talent. We proudly support our international employees by offering assistance with critical skills visa applications for eligible candidates.

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