My client's business is a leader in medical imaging worldwide, offering a wide range of pharmaceutical products, medical devices, digital and AI solutions for diagnostic and interventional imaging. A track record in building lasting relationships so that this organisation enables people to live better lives. The businesses purpose is placed around human cooperation at the heart of the organisation's relationships and actions. A pioneer for 95 years in the field of contrast media, this businesses team consists of over 4,000 people globally, continuously innovating with 10% of revenue dedicated to Research & Development across four centres around the world including a state of the art manufacturing plant here in Ireland that is seeing consistent growth and investment.

The Position:

• Lead the GMP compliance efforts for a Pharma production process related to the site.
• Lead site cross-functional Kaizens and continuous improvement initiatives from conception to closure, with specific focus on Quality and Laboratory driven improvements.
• Various Quality Systems and Quality Operations activities including but not limited to:
  • Participate in Quality Management System Harmonisation activities.
  • Manage the calibration of GMP Service Providers in QC Laboratory.
  • Responsible for completion of Data integrity admin checks.
  • Represent Quality in support of Deviations, Change Controls, CAPAs, etc., including active participation in investigations and problem resolution.
  • Complete batch record review on the shop floor.
  • Perform API Product Release.
  • Review and approve Quality records(CAPA, deviations, OOS).
  • Prepare, review data and reports including annual product quality review reports.
  • Participate in the internal auditing program.
  • Participate in the Supplier management program.
  • Lead method development and validation initiatives.
  • Edit, review and approve GMP documents.
• Ensure that EHS roles and responsibilities are complied with as per the requirements of the site Safety Statement.
• Perform other related duties as assigned from time to time based on company needs.

The Person:

• Minimum of a Bachelor Degree in Science or related pharmaceutical discipline.
• Minimum 3 years' experience within the pharmaceutical industry.
• Desirable evidence of Continuous Professional Development.
• Understanding of EU GMP Complexity.
• A proven identifiable track record of success in a similar environment.
• Good organizational skills and attention to detail.
• Requires good written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally.
• Ability to prioritize, manage multiple tasks, and meet deadlines.
• Ability to learn and utilize computerized systems for daily performance of tasks.

Key Additional Competencies

• Strong Interpersonal Skills
• Strong Functional / Technical skills
• Ambition coupled with Ability
• Decision Quality
• Managing & Measuring Work
• Learning / Change Agility
• Drive for Results
• Continuous Improvement mindset

To learn more about this role apply online or contact Anita Osibuamhe at or +353 1 6321870 for a confidential discussion.