Quality Specialist – Quality Systems

4 weeks ago

Cork, Cork, Ireland TN Ireland Full time
Quality Specialist – Quality Systems

The Quality Specialist – Quality Systems supports the Quality Systems activities in both the Drug Substance and Drug Product.

Key Responsibilities:
  • Timely and effective completion of the Quality Systems core functions in accordance with schedules and policies, procedures and guidelines.
  • Sub system ownership responsibilities as per the site System Ownership list.
  • Quality SME for Process, Cleaning, Water, Equipment: Leadership through knowledge and skill regarding validation standards required for a Drug Substance and Drug Product pharmaceutical facility.
  • Participating in and supporting the site PVC, WVC, CVG, and EQVC committees.
  • Approval of all validation documentation and ensuring compliance to policies, procedures and guidelines.
  • Supports the implementation of site or capital projects by defining validation requirements and providing technical assistance and support as a member of the project teams.
  • Developing Validation Summary Reports and assisting in developing overall Quality plans for major projects.
  • Working with other areas in industry to predict future trends in validation and determining best practice.
Quality Council:
  • Managing the annual quality council schedule.
  • Managing the monthly quality council agenda, minutes and action follow up.
Supplier Change Evaluations - Quality Role:
  • Reviewing and approving Supplier Change Evaluation documentation.
  • Generating quality/technical agreements with suppliers as appropriate.
Supplier and Customer complaints:
  • Participating in the investigation and review of any internal/external customer complaints in accordance with agreed lead-times.
  • Participating in the investigation and review of any supplier complaints in accordance with agreed lead-times.
Filing & Licence maintenance and Regulatory Requests follow ups:
  • Reviewing and ongoing maintenance of site licenses.
  • Providing site documentation to support product filings in accordance with CMC requests.
QA Regulatory Data:
  • Reviewing and verifying documentation that may be used for submission to Pharm-CMC or other requester(s) for regulatory submissions/filings.
  • Assuring the accuracy and integrity of all data and information through a timely review program.
Returned Goods:
  • Managing the segregation and disposition of all returned goods.
  • Supporting the internal GMP walk-down and scheduled audits program.
  • Supporting hosting of site Regulatory Inspections.
Qualifications:
  • Minimum of Degree or post-graduate qualification in Science, Pharmacy or Engineering field.

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