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eSystems Compliance Officer

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Waterford
  • Sector: Quality & Compliance
  • Date posted: 12/01/2018
  • Job reference: J379895A

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eSystems Compliance Officer

Our client, a world-leading Pharmaceuticals company based in Waterford, are currently recruiting for an eSystems Compliance Officer to join our expanding Quality Systems Team.

This person's duties will include assisting team(s) with:

The preparation of validation related documentation, standard operating procedures, reports and system quality reviews

Identifying deficiencies

Preparing CAPA documents, test scripts and change controls with regards to automated systems validation.

The ideal candidate will be able to ensure that site automated systems are introduced, maintained and are operating in accordance with cGMP's, site and corporate policies and regulatory requirements with a keen focus on Data Integrity.

Essential criteria:

- Relevant third level degree in pharmaceutical science, quality management, computer science, computer engineering, life science, or any other pertinent degree.

- A minimum of 3 years' experience in pharmaceutical industry, within a quality or IT function.

- Experience with relevant quality systems

- An in-depth knowledge of FDA and European compliance regulations and GAMP guidelines applicable to computer system validation.

The role offers a competitive salary with benefits package.

For a more detailed role description or information on other positions, please contact Kathryn on 01-6455244/ 087 3555378 or