Analytical Process Specialist

2 weeks ago

Dublin, Dublin City, Ireland beBeeQuality Full time €60,000 - €80,000
Quality Assurance Professional Role Overview:
  • The Quality Control Specialist will develop and implement QC systems, sampling plans, and testing strategies to ensure compliance with quality standards.
  • Collaboration with internal/external teams is required to guarantee adherence to GMP/GLP regulations.
  • Reviewing and executing documentation (SOPs, CoAs, test methods, reports, investigations) is essential for maintaining accurate records.
  • Investigating out-of-spec/limit results and leading CAPA implementation are critical tasks in this role.
  • SUPPORTING analytical training programs and driving continuous improvement initiatives are also key responsibilities.
  • Maintenance of lab systems (e.g., LIMS, LabX, UV software) and good housekeeping practices are necessary for efficient laboratory operations.
Required Skills & Qualifications:
  • At least 2 years of experience in a GMP pharmaceutical environment as a Quality Control Specialist.
  • A scientific degree is required, with a postgraduate qualification being advantageous.
  • Proficiency in QC documentation and laboratory investigations is expected.
  • Strong knowledge of analytical systems and quality standards is necessary for success in this role.
  • Excellent problem-solving, organization, and cross-functional communication skills are required.
  • Ability to work independently and within a team-focused environment is essential.
Key Responsibilities Include:
  • Development of QC systems and sampling plans.
  • Collaboration with internal/external teams.
  • Review and execution of documentation.
  • Investigation of out-of-spec/limit results.
  • SUPPORT OF analytical training programs.
  • Maintenance of lab systems.

Analytical Systems Experience

This role requires strong knowledge of analytical systems and quality standards. The ability to apply this knowledge to develop and implement effective QC systems and processes is crucial.

Quality Standards Compliance

The Quality Control Specialist must ensure that all activities and processes comply with relevant quality standards and regulations.

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