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Regulatory Compliance Specialist

2 weeks ago

Carlow, Ireland Psc Biotech Corporation Full time

At PSC Biotech Corporation, we are seeking a talented Regulatory Compliance Specialist to join our Engineering Department. In this role, you will play a crucial part in ensuring that our company's products meet the highest quality and safety standards.

About Us

PSC Biotech Corporation is a leading Biotech Consultancy firm with operations globally. We provide cloud-based software solutions for Quality Management and Regulatory Inspections to our clients in the pharmaceutical and biotechnology industries.

Responsibilities

  • Support the Engineering Department in maintaining a GMP-compliant environment
  • Conduct failure analysis, root cause determination, and implement corrective actions
  • Analyze Engineering metrics reports to identify areas for improvement
  • Develop and maintain necessary documentation, including SOPs, SWIs, training documents, JSAs, PMs, and change controls
  • Collaborate with Engineering colleagues and other departments to ensure compliance with global policies, procedures, and regulatory requirements

Requirements

  • Degree in a related field (diploma or higher preferred)
  • Minimum 4-5 years of experience in a manufacturing setting, preferably in a GMP environment
  • Strong understanding of regulatory/code requirements, including Irish, European, and International Codes, Standards, and Practices
  • Effective communication and interpersonal skills, with ability to interface effectively with all levels of colleagues and external customers