Quality Assurance Specialist

2 weeks ago

Waterford, Waterford, Ireland beBeevalidation Full time €60,000 - €80,000

Job Opportunity:

Quality Assurance Specialist

We are seeking a skilled Quality Assurance Specialist to join our team. The ideal candidate will have a strong background in quality management and be able to ensure ongoing compliance with relevant standards and regulations.

The key responsibilities of this role include:

  • Validation Management: Design, execute, and report on PV/Process Performance Qualifications, validation studies for equipment, systems, and processes.
  • Technical Interpretation: Provide technical interpretation and guidance on current US FDA and EU validation requirements for aseptic processing, lyophilisation, sterilisation, and dehydrogenation.
  • Documentation: Maintain validation documentation throughout the validation lifecycle.
  • Regulatory Compliance: Ensure validation studies are managed in conjunction with relevant standards and legal requirements (Health & Safety, cGMP, construction, environmental, etc.).
  • Collaboration: Participate in external regulatory inspections and support Site Change Control process.

Requirements:

  • Degree and Experience: Degree in Science (Chemistry, Micro., or Pharmacy preferred) or Engineering (Chemical/Mech/Elec), 3-5 years' experience working in a healthcare manufacturing environment – ideally within the pharmaceutical sector.
  • Skills and Knowledge: Capable of troubleshooting validation issues associated with projects, process development, etc.; competent technical knowledge of pharmaceutical plants; previous validation/product development experience is highly advantageous.
  • Industry Expertise: Familiarity with GAMP, ISPE Baseline guides, AAMI/ANSI, PDA, and ISO guidelines.
  • Quality Management: Strong understanding of quality management systems and relevant regulations.

Preferred Skills:

  • Software Proficiency: Ability to use MS Project and SPC packages.
  • Quality Management Systems: Good knowledge of quality management systems.
  • KPIs: Understanding of KPIs for the site.

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