GMP Quality Assurance Professional

1 week ago


Cork, Cork, Ireland PSC Biotech Corporation Full time

About PSC Biotech Corporation

We are a leading Biotech Consultancy firm founded in 1996, headquartered in the US, with global operations in Ireland, India, Singapore, Australia, and the US, serving clients in over 23 countries worldwide.

PSC Biotech provides innovative solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

Employee Value Proposition:

Our employees are empowered to drive their careers forward through our Learning & Development programs, in-house training, and mentorship.

Job Details:

The Pharmaceutical Quality Assurance Specialist is a member of a team within Quality and is involved in supporting GMP Quality Assurance activities at the facility.

Key Responsibilities:

  • Verify the accuracy of production and analytical documentation accompanying the release of drug substance, drug product, and packaged finished goods to SOPs, GMP, and regulatory requirements.
  • Investigate and resolve complaints and deviations, and implement corrective actions.
  • Develop and maintain SOPs and document changes.
  • Present findings in reports and presentations.
  • Conduct audits to ensure compliance with SOPs, GMPs, and regulations.
  • Support product recalls and stock recoveries as necessary.
  • Develop effective working relationships with functional areas.
  • Implement recommendations for continuous improvement.
  • Support new starters and train other staff members.

Skills and Education:

  • A degree in a Science or Engineering discipline, or significant industrial experience.


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