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Contact Info
Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Quality Defects and Recall Inspector


Reference:SCARQB-722321 Location: Dublin
Qualification:DegreeExperience:3-4 Years
Job Type:Fixed Term ContractSalary: Not Disclosed

Quality Defects and Recall Inspector
Our client, a large regulatory body, are currently recruiting for a Quality Defects and Recall Inspector to join their team. As Quality Defects and Recall Inspector you will perform risk-based technical evaluations and assessments of suspected and confirmed Quality Defect reports on medicines and active substances, and performing for-cause GMP and other inspections, as required, in relation to serious QDR issues. You will review and/or recommend actions that are designed to remediate and correct the non-compliance issue at hand, to ensure patient and animal safety.

Requirements

  • Perform screening and risk assessments on incoming reports of suspected quality defects in medicines and active substances, identifying high-risk cases for prioritisation
  • Perform technical investigations of suspected quality defects, including approval of risk classifications and proposed market actions in line with relevant policies, procedures and guidelines, including Quality Risk Management principles
  • Coordinate recall actions, where required, including drafting, reviewing and approving recall letters, and reviewing recall reports
  • Coordinate the issuance of notifications to other competent authorities, where required, including drafting, reviewing, approving and signing
  • Approve or request for-cause GMP and GDP inspections, in relation to serious QDR issues, where required
  • Lead for-cause GMP and GDP inspections, where required
  • Generate, maintain and review records of meetings, QDR investigations and actions, including case files and QDR registers
  • Together with the QDR Manager, ensure the QDR programme remains up to date with current EU and national legislation, international standards and guidelines
  • Support the Market Compliance Manager and QDR Manager in the generation of annual, monthly and other QDR reports, as required
  • Compilation of data to identify trends and key learnings from the QDR programme
  • Work to ensure that available information and knowledge across the organisation is effectively used by the QDR programme

Requirements
  • A 3rd level (honours) degree in a relevant scientific or related discipline
  • A minimum of three years of relevant experience in one or more of the following: a facility that manufactures medicinal products, a Regulatory Authority- working as an investigator of quality defects in medicinal products or as a GMP Inspector or in pharmaceutical assessment, or in another relevant area, a Retail or Hospital Pharmacy – working as a dispensing pharmacist
  • Excellent working knowledge of the EU GMP requirements, particularly those elements relating to the Pharmaceutical Quality System, Quality Defect/Complaint investigations, Root Cause Analysis and CAPA (Corrective Actions and Preventative Actions)
  • Good working knowledge of Quality Risk Management
  • Proven ability to work unsupervised and in a leadership role
  • Proven ability to work with others in a collaborative and solutions-focused manner
  • Proven ability to work effectively as part of a multi-disciplinary team
  • Proven ability to gather technical and other information and to apply analytical skills to reach risk-based decisions on technical issues
  • Proven ability to deal with large volumes of cases and workload and to prioritise based on quality risk management principles
  • A high level of motivation and the ability to comply with and manage deadlines
  • A high level of demonstrated initiative
  • Excellent computer skills, in particular MS Office applications
  • Excellent communication skills with the proven ability to deliver appropriate information to the right people using a range of written, verbal and presentation skills
In addition, the following would be considered an advantage:
  • A post-graduate qualification in a relevant scientific or related discipline
  • Direct experience in the investigation of quality defects in medicinal products will be a distinct advantage
  • Relevant experience in the collation, evaluation and presentation of scientific data
  • Experience in the development or implementation of quality management systems
  • Exposure to, or experience of, GMP and/or GDP Inspections