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Associate Director Quality Assurance

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Swords, Dublin
  • Sector: Quality & Compliance
  • Date posted: 31/10/2018
  • Job reference: BBBH91675

SK biotek Ireland is seeking to hire an Associate Director of Quality Assurance on a permanent basis. Reporting to the Quality Director, the successful candidate will play a lead role in our quality team on site. This position is critical to ensure sustainable compliance of the site as we continue to grow though expansion of the site and increase our customer portfolio.

This is a diverse role with responsibility for the QA Operations, Systems and Validation activities on site

Responsibilities include but are not limited to:

  • Provide compliance leadership across the site ensuring the site operates to the applicable cGMP and international standards for our customers on a daily basis
  • Maintain the very strong compliance reputation gained by the Swords site through multiple PAI and GMP inspections
  • Lead the site in the preparation for customer and Regulatory inspections with expectation for minimal audit findings
  • Support the effective transfer of NPIs in collaboration with the site cross functional team
  • Mentor and coach a highly skilled, professional quality assurance team to ensure batch release, product performance, product quality reviews and other cGMP documentation, including SOPs, policies, and manufacturing documentation are completed to the required standards.
  • Ensure an effective and timely deviation/customer complaint management system with robust root cause analysis, appropriate CAPAs and effectiveness review.
  • Ensure an effective change management system is in place with appropriate use of risk based principles
  • Manage the site Quality Council Process ensuring that appropriate metrics are in place for the effective monitoring of the quality system
  • Drive the development and implementation of new techniques, systems and initiatives to enhance the quality system on site. Champion continuous improvement with particular focus on right first time and lean methodologies
  • Ensue that validation activities (computer, equipment and process) are completed in line with cGMP and international standards

Experience:

  • The successful candidate will possess strong Quality and people Management.
  • The candidate must have a strong understanding of the key business drivers of the industry/organisation.
  • Candidates should hold at minimum a Bachelor's Degree in Science, Engineering or similar technical discipline.
  • Advanced qualifications are desirable and at least 10 years' experience in the Pharmaceutical industry.

Excellent communication and organisational skills with demonstrated expertise to effectively communicate within all levels of the organisation is required. Demonstrated ability to lead, cross functional teams and make decisions in pressurised situations to ensure compliance.

For further information, please contact Dominic on 01-6455254 or at dominic.callanATexperis.ie