Product Compliance Specialist

2 days ago

Dublin, Dublin City, Ireland beBeeQuality Full time €60,000 - €85,000
Batch Release Specialist Job Overview

The Batch Release Specialist plays a crucial role in ensuring the quality and compliance of manufactured products. The specialist is responsible for preparing product release dossiers, reviewing batch manufacturing and packaging records, artwork, quality notifications, transportation and temperature records, sampling plans and test results.

  • Prepare and present product release dossiers to Qualified Persons (QPs) to support compliant batch release.
  • Escalate any issues identified, review associated records and documentation, including deviations and liaise with the manufacturing site/External Quality and QP to understand the impact of the deviation on product quality prior to release.
  • Raise and track Transport Incident Logs (GTIL) for transit temperature excursions, liaising with the Pharma Logistics Operations groups and supplying sites to resolve and close, ensuring escalation to the QPs.

The successful candidate will communicate effectively with cross-functional teams, including Supply Chain Hubs, Local Operating Companies, manufacturing sites, External Supply Quality managers and importation warehouse, providing feedback to all on progress of release as required.

Qualifications/Skills:
  • Basic Qualifications:
    • Degree in a relevant science field (e.g., Pharmacy, Chemistry, Biology).
    • Experienced in manufacturing site operations, batch record review, quality data review and operational quality requirements.
    • Knowledge of GMP (Good Manufacturing Practices) and GDP (Good Distribution Practices) regulations.
  • Preferred Qualifications:
    • Understanding of quality management principles and documentation requirements (ALCOA+) for GMP compliance.
    • Capable of working in multi-disciplinary teams across IT, Quality, External Supply, Global Logistics, Supply Chain and Manufacturing.
Career Benefits:
  • Competitive salary.
  • Annual bonus based on company performance.
  • Healthcare and wellbeing programmes.
  • Pension plan membership.
  • Shares and savings programme.
  • Modern work practises; Performance with Choice programme offers a hybrid working model.

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