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QA Officer

Expired
  • Salary: Negotiable
  • Job type: Contract
  • Location: Dublin
  • Sector: Science
  • Date posted: 15/06/2017
  • Job reference: J368383A

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QA Officer

We are currently recruiting for a QA Officer for a leading company based in Dublin.

In this position, you are responsible for carrying out tasks and projects related to management of Quality Assurance activities as required by Good Manufacturing Practice (GMP). These activities include risk assessment, Change control, system updates, process verification, and Annual product review and validation compliance activities. Also, you would be required to provide support to relevant departments in respect of specific quality system elements to ensure business, quality and compliance goals are met.

Key Responsibilities:

  • Batch Record Review & material release to ensure compliance with GMP Requirements.
  • Carries out tasks related to the administration of event management systems including review & Approval, Deviations, and Validation. Carries out tasks related to the management of batch records design and approval.
  • Ensures that Batch Operating Instructions are compliant with filed descriptions
  • Carries out tasks relating to the management of site change control systems.
  • Compiles Annual Product Reviews.
  • Supports all validation activities on site as described in the Site Validation Master Plan.
  • Approves and compiles where appropriate validation protocols and reports (analytical, cleaning, computer, process, equipment, etc.).
  • Supports system qualification and process validation activities.
  • Reviews and approves SOPs/work instructions/forms from other departments on behalf of Quality Assurance
  • Co-ordinates and assists in the preparation for regulatory and customer GMP inspections of the site.
  • Participates in the introduction of new process or modified process steps, as part of a New Product Introduction Team (NPI)
  • Perform GMP audits on-site and vendor facilities as required.
  • Carries out tasks related to the administration of site supplier approval process.
  • Adheres to and supports the company safety policy and safety programmers.

Required Qualifications:

  • Minimum of 2 years' experience in a similar role
  • Experience working in a GMP environment is required
  • Excellent accuracy and attention to detail
  • Excellent interpersonal skills
  • Good presentation skills
  • Working knowledge of computer packages

For more information please contact Kathryn on 01 6455250 or email

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