QA Specialist

Morgan McKinley View all jobs

  • Dublin
  • Contract
  • Full-time
  • 1 month ago
Provides support to Qualified Person (QP) for R&D supplies shipped through EU Central Warehouse (EUWH) and provides QA support to Clinical Supply Logistics.The successful candidate will hold a BSc in Science or related discipline, with relevant QA or related experience in a Pharmaceutical environment. A clear understanding of cGMP requirements for manufacturing and/or systems and compliance. The candidate should also be open to travel in support of their role, where necessary.The QA specialist will be required to work on his/her own initiative in addition to working as part of a team. The candidate must be able to work across a team matrix in order to meet accelerated timelines. Excellent communication & presentation skills are essential. The successful candidate must demonstrate excellent time management & organisational skills along with a proven ability to multi-task.Key Responsibilities and Major Duties
  • Compiles Qualified Person batch release dossiers
  • Supports Packaging & Labelling activities performed at EUWH.
  • Provides Quality Assurance support in the Use Date Extension process.
  • Provides Quality Assurance support (GMP/GDP guidance and training) for CSO Regional Logistics.
  • Support in a timely manner, the investigations of non-conformances and quality incidents. Resolves and documents into Quality Management System deviations or problems pertaining to the review of documents. Conducts appropriate follow-up as required. Tracks deviation, investigations and CAPAs.
  • Authors ISR related Quality agreements, keeps agreements current and manages updates required.
  • Prepares release dossiers for ISRs
  • Prepares and reviews procedural documents as requested by supervisor.
  • Support preparation of training materials.
  • Contribute to improving and maintaining CSCQ QMS
  • Prepare and approve supply chain flow maps, and product specification files.
  • Authoring, review, and approval of QA-related procedures
  • Supporting generation of/updates existing Quality Agreements.
  • Adherence to clients core behaviours

Morgan McKinley