Quality Assurance Specialist

3 days ago

The Municipal District of Carlow, Ireland PSC Biotech Corporation Full time
About PSC Biotech Corporation

PSC Biotech Corporation is a leading biotechnology consultancy firm that has been at the forefront of innovation since its founding in 1996. Headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US, our company serves over 350 clients across more than 23 countries worldwide.

Our commitment to excellence is reflected in the provision of cloud-based software solutions for quality management and regulatory inspections, catering to the needs of pharmaceuticals contract manufacturing professionals and metrology services.

Role Functions
  • Design, author, review, approve, and execute qualification/validation documentation and cycle development studies in accordance with established approval processes.
  • Develop and execute change controls, ensuring seamless integration into existing workflows.
  • Analyse and resolve technical issues encountered during study execution, applying expert knowledge to optimise outcomes.
  • Collaborate with production, maintenance, and quality representatives to ensure successful execution of Cycle Development & Performance Qualification activities.
  • Author and review technical inputs for quality notifications, ensuring accurate and comprehensive investigations.
  • Conduct root cause analysis of system failures and substandard performance, utilising standard tools and methods to resolve machine and system issues.
  • Promote continuous improvement through Lean Six Sigma methodologies, driving process enhancements and efficiencies.
  • Represent the validation team at global technical forums, fostering cross-functional collaboration and knowledge sharing.
  • Ensure compliance with Global Policies, Procedures, and Guidelines, regulatory requirements, and current Good Manufacturing Practices (cGMP) throughout day-to-day activities and job functions.
  • Accountable for compliance via documentation completion, risk assessments, corrective actions, participation in audits and inspections, and proactive issue highlighting.
  • Support regulatory audits and submissions as required, maintaining high standards of professionalism and attention to detail.
  • Foster a safe and compliant culture, collaborating with colleagues to drive excellence and success.

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