Senior Quality Assurance Specialist

6 days ago


Cork, Cork, Ireland LSC, Life Science Consultants Full time

Job Description:

  • LSC, Life Science Consultants have a great contract opportunity for an Associate Quality Specialist to join a global Biopharmaceutical company in the industry.
  • The facility specializes in the fermentation, purification, and sterile filling of biotech products, as well as supporting product development and clinical trials.

About the Project - Key Responsibilities:

  • Provides expertise in Quality Systems and/or Operational Quality, including 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.
  • Required to be proficient in Quality approval and oversight for Commissioning and Qualification activities (IQ/OQ/PQ)
  • Provides compliance contribution to project teams and leads small projects.
  • Coaches and guides colleagues within the site.
  • Participation in inspections of Site by Divisional / Regulatory Bodies / third parties together with follow up actions where applicable.
  • Deviation Management & Change Control approval.
  • Champion the highest Quality and Compliance standards for the site.

About You - Are Your Skills a Match?

  • 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.
  • 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.


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