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GMP Auditor and Quality Specialist

1 week ago


Cork, Cork, Ireland Recruitment by Aphex Group Full time

Job Title: GMP Auditor and Quality Specialist

Job Summary:

We are seeking a highly skilled GMP Auditor and Quality Specialist to join our team at Recruitment by Aphex Group.

About the Role:

The GMP Auditor and Quality Specialist will be responsible for ensuring compliance with Good Manufacturing Practice (GMP) regulations and Company SOPs. This includes reviewing and approving production and analytical documentation, performing complaint investigations, and analyzing deviations from established procedures.

Key Responsibilities:

  • GMP Documentation Review: Conduct thorough reviews of production and analytical documentation to ensure adherence to GMP requirements and Company SOPs.
  • Complaint Analysis: Investigate customer complaints and identify root causes to implement corrective actions.
  • Deviation Investigation: Analyze and investigate deviations from established procedures, recommending corrective actions to prevent recurrence.
  • SOP Development and Maintenance: Develop, maintain, and update Standard Operating Procedures (SOPs) related to quality assurance and regulatory compliance.
  • Audit Preparation and Execution: Assist in preparing for and executing audits and inspections to ensure compliance with regulatory requirements.

Requirements:

  • Education: Bachelor's degree in a Science or Engineering discipline.
  • Experience: Significant experience in a quality assurance or regulatory compliance role, preferably in a pharmaceutical industry setting.
  • Skills: Strong knowledge of GMP regulations, SOP development, and audit preparation.