Quality Assurance Expert

1 day ago

Cork, Cork, Ireland beBeeQuality Full time €55,000 - €75,000
Job Summary

We are seeking a highly skilled Quality Assurance Expert to join our team. This role is responsible for ensuring the quality of our products and services, in accordance with regulatory requirements and industry standards.

Main Responsibilities:
  • Deliver Quality Assurance support to the Packaging Department.
  • Evaluate and approve GxP documentation.
  • Conduct Batch Record Review and Batch Disposition processes.
  • Update Quality Assurance Standard Operating Procedures (SOPs) as necessary.
  • Scan and archive documents as needed.
  • Inspect finished products.
  • Perform investigations into deviations and conduct Root Cause Analysis.
  • Generate reports for customer complaints.
  • Conduct line clearance 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.
Required Skills and Qualifications:
  • A relevant third-level qualification in a QA discipline.
  • A 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 is 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 the 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.
  • A proactive attitude toward customer service and performance.
Benefits:

Catalyx offers a comprehensive benefits package that includes great personal benefits and professional growth opportunities. We strive to create a diverse and inclusive workplace where all individuals are valued, respected, and supported.

About Us:

We are an Equal Opportunity Employer 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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