Biotech Quality Assurance Specialist

1 week ago


Dublin, Dublin City, Ireland Psc Biotech Full time

About PSC Biotech

PSC Biotech is a leading biotech consultancy firm founded in 1996. We provide cloud-based software solutions for quality management, regulatory inspections, and pharmaceutical contract manufacturing professionals.

As a quality assurance specialist at PSC Biotech, you will have the opportunity to work with a talented cohort of like-minded professionals in the pharmaceutical industry.

We offer a permanent contract of employment giving exposure to working in top pharmaceutical client sites in a diverse cultural work setting.

Key Responsibilities

  • Provide direct quality support to a production area as part of a quality IPT (Integrated Product Team)
  • Ensure quality and compliance of products manufactured by the functional area
  • Review process documentation/data for accuracy, completeness, and data integrity compliance
  • Conduct investigations of deviations and participate in continuous improvement initiatives
  • Support the completion of batch disposition activities for release of product

Requirements

  • Minimum 5 years of relevant post-degree work experience in GMP manufacturing, quality assurance, or laboratory environment
  • Expertise in QA operations and regulatory agency engagement an advantage
  • Candidates should possess strong leadership skills, good oral and written communication skills, and understanding of cGMPs and regulatory requirements


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