Senior Quality Assurance Professional

2 days ago


Dublin, Dublin City, Ireland beBeeQuality Full time €60,000 - €80,000
Job Opportunity

CPL in partnership with SK pharmteco is hiring a permanent Quality Assurance Senior Specialist to join the QA Systems team at their site in Dublin.

SK pharmteco is a global Contract Development and Manufacturing organisation (CDMO) with state-of-the-art facilities in Korea, US, France and Ireland. We are part of SK Inc., a Korean company with revenues of $99 billion.

The SK pharmteco Small Molecule, Europe, facility located in Dublin has led the way in the development, scale-up and commercial manufacture of Active Pharmaceutical Ingredients (APIs) and Chemical Intermediates for over 60 years.

As a Quality Assurance Senior Specialist, you will be responsible for:

  • Collating Site Quality Metrics and monitoring trends with actions.
  • Leading the monthly Site Quality Management Review.
  • Providing oversight of Supplier qualification.
  • Back-room lead for all customer audits and regulatory inspections.
  • Part of the internal Audit team on site.
  • Main point of contact for all licensing.
  • Assisting with Assessment and QA Approval of changes for GMP compliance.
  • Reviewing and approving GMP SOPs.
  • Ensuring that all activities meet GMP regulations, site or corporate quality standards.

The ideal candidate will possess:

  • A Bachelor's or Master's degree in Chemistry or a related scientific field.
  • Minimum 3 years of experience in the pharmaceutical industry in a similar role.
  • Strong initiative and ability to work independently and collaboratively across the organization.
  • Alignment with SK pharmteco Values and Behaviours.

Desired/Advantageous qualifications include:

  • Previous experience in QA Systems generating Site Quality Metrics.
  • Previous experience in Supplier Qualification.
  • Experience in Clinical to commercial manufacturing.
  • Lean Six Sigma – proven track record improving Systems processes.
  • Experience in back room for regulatory inspections or part of Inspection readiness team.

This is an excellent opportunity for career enhancement and personal development, with a competitive base salary, annual bonus linked to business results, further education program, pension scheme, private healthcare, and more.

ResponsibilitiesKey Responsibilities:
  • Site Quality Metrics
  • Monthly Quality Management Review
  • Supplier Qualification
  • Audits and Inspections


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