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QMS Specialist

  • Salary: Negotiable
  • Job type: Contract
  • Location: Tipperary
  • Sector: Quality & Compliance
  • Date posted: 26/09/2018
  • Job reference: BBBH15253

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QMS Specialist


  • The QMS Specialist is responsible for the execution and maintenance of key Quality documents. This position is responsible for coordination, implementation, and daily management of documentation distribution and maintenance of quality documents required for the use in manufacturing, testing, and packaging of product. Other key accountabilities include: issuance of logbooks, request for reviews, execution and maintenance batch record. This position will interact with other operating and staff groups within the Organization including, but not limited to Operations, Purchasing, R&D, Site Quality, Quality Engineering and Sales/Marketing.

Essential Functions:

      • Reviews & monitors NC/NOI/CAPA's to closure
      • Reviews & monitors SOP's and Change Controls actions through to closure
      • Generates and issues Batch Records to production.
      • Retrieves executed Batch Records from QA.
      • Maintains files stored in document room and readily retrieves upon request.
      • Maintains, stores and controls document
      • Maintains hard copy change controls
      • Maintains Master Formulation Documents, Packaging Orders and specifications.
      • Distributes all Controlled Documents; Issues Logbooks for production and testing purposes.

Additional Responsibilities:

  • Archives Batch Records and maintains inventory


  • Level 8 Qualification in Quality/Engineering related discipline


  • Minimum 3+ years in a QA, QMS, Quality/Validation Engineering, or similar role within the Medical Device or Pharmaceutical Industry.


  • Ability to multi-task and flexibility to accommodate changing priorities
  • Strong process and regulatory knowledge
  • Customer service oriented
  • Strong communicator with the ability to influence
  • High accountability and ownership