Quality Specialist

QAS_1706714964
  • €75000 - €85000 per anuum
  • Contae Chorcaí
  • Contract


The Quality Specialist will participate and comply with the Quality Management System (QMS) requirements, including ownership as required.

Primary activities/responsibilities:

  • Required to be proficient in Quality approval and oversight for Commissioning and Qualification activities (IQ/OQ/PQ)
  • Provides to the site expertise in Quality Systems and/or Operational Quality, including the following i.e. Quality Notifications/Investigations/ Change Management; environment monitoring programs; sterility assurance/low bioburden manufacturing; etc.
  • Uses knowledge to improve Quality Systems and/or Operational Quality; solve complex problems, provide continuous improvement and execute tasks.
  • Acts as a resource to colleagues with less experience in Quality Systems and/or Operational Quality
  • Understands and applies regulatory / compliance requirements to their role together with remaining current on upcoming regulatory and compliance changes
  • Interprets customer needs, assesses requirements and identifies solutions to non-standard requests.
  • Makes decisions within guidelines and policies which impact Product Quality, Projects and Quality Systems.
  • Uses knowledge to improve Quality Systems, solve problems, provide continuous improvement, and execute tasks.
  • Provides compliance contribution to project teams and leads small projects.
  • Coaches and guides colleagues within the site.
  • Responds to non-standard requests from customer needs.
  • Makes decisions within guidelines and policies which impact own priorities and allocation of time to meet deadlines.
  • Supports Corporate Quality to ensure actions related to Quality Systems at the site are executed.
  • Participation in inspections of Site by Divisional / Regulatory Bodies / third parties together with follow up actions where applicable.
  • Participate in GMP Walkthroughs.
  • Deviation Management & Change Control approval.
  • Ensures supply of high-quality product through the implementation and oversight of the Quality Management System for the site.
  • Champion the highest Quality and Compliance standards for the site.
  • Ensure highest safety standards.
  • Additional activities as requested by QA Lead

Required:

  • Degree or 3rd level qualification (Science, Quality).
  • Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation.
  • 5 years' experience in the pharmaceutical industry or a similar operating environment which includes experience in a Quality function
  • Quality Assurance SME knowledge, from both operational and educational experience, is required.
  • Knowledge and experience in interpreting current regulatory requirements and providing independent support to the site
  • Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance.
  • Demonstrated ability to work and succeed within teams as well as leading small project teams.
  • Demonstrated ability to drive the completion of tasks.
  • Proven track record of providing independent Quality support to the site.
  • Advanced PC skills such as Excel, Word, PowerPoint.
  • Stakeholder management of multiple decision makers, auditors, cross functional teams by demonstrating the ability to maintain and strengthen trust relationships with people on all levels.
  • Proven decision-making capability with full accountability and responsibility.
  • Energetic with proactive & positive attitude.
  • Demonstrated coaching skills.
  • Demonstrated ability to solve problems.
Christopher Cahill Principal MSP Consultant

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