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Quality Assurance Specialist

1 week ago

Nenagh, County Tipperary, Ireland Pe Global Full time
Job Description:

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

This role is a key member of the Quality Systems Team, responsible for ensuring timely and effective completion of Quality Systems core functions in accordance with schedules and policies, procedures, and guidelines.

Key Responsibilities:

  • Complete sub system ownership responsibilities as per the site System Ownership list
  • Provide leadership on validation standards required for a Drug Substance and Drug Product (SDI & OSD) pharmaceutical facility
  • Participate in and support site committees such as PVC, WVC, CVG, and EQVC
  • Approval of all validation documentation and ensuring compliance to MMD policies, procedures, and guidelines
  • Ensure that validation status is maintained following changes/modifications
  • Support implementation of site or capital projects by defining validation requirements and providing technical assistance and support
  • Develop Validation Summary Reports and assist in developing overall Quality plans for major projects
  • Works with other areas in MMD and industry to predict future trends in validation and determine best practice
  • Principle Quality contact for all site change requests (with impact on processing)
  • Laboratory QA oversight Support and approve the systems supporting laboratory functions, instrumentation, and GLIMS
  • Provide Quality oversight and approval for laboratory incidents/investigations and documentation
  • Review and approval of stability reports
  • Microbiology Point of Contact
  • Manage site inventory of Quality Agreements and ensure Quality Agreements are raised for all required relationships
  • Interact and communicate with SD&PM, relevant stakeholders, and external parties to ensure appropriate Quality Agreements are current, approved, on file, and retrievable
  • Annual Review System Management Manage the system ensuring that Annual Reviews (AR/APR/PQR) for products and systems incl automation, are completed to meet the Annual Review schedule
  • Creation, review, and approval of Site Quality documentation including Site Master File, Validation Master Plan, policies, or procedures
  • Quality Oversight of site application User Access Reviews Approval of all designated user access reviews, ensuring compliance with site and MMD policies and procedures
  • Manage the annual quality council schedule
  • Manage the monthly quality council agenda, minutes, and action follow-up
  • Supplier Change Evaluations - Quality Role Review and approve Supplier Change Evaluation documentation
  • Complete/Approve MDS updates post SCE approval Approve Supplier Transparency update change requests post SCE approval Generate quality/technical agreements with suppliers as appropriate
  • Participate in the investigation and review of any internal/external customer complaints in accordance with agreed lead-times
  • Participate in the investigation and review of any supplier complaints in accordance with agreed lead-times
  • Filing & Licence maintenance and Regulatory Requests follow-ups Review and ongoing maintenance of site licences Provide site documentation to support product filings in accordance with CMC requests
  • Review and verify documentation that may be used for submission to Pharm - CMC or other requester(s) for regulatory submissions/filings
  • Assure the accuracy and integrity of all data and information through a timely review program
  • Manage the segregation and disposition of all returned goods
  • Audit program Support the internal GMP walk-down and scheduled audits program Support hosting of site Regulatory Inspections