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Quality Systems Specialist

  • Salary: Negotiable
  • Job type: Contract
  • Location: Waterford
  • Sector: Science
  • Date posted: 13/10/2017
  • Job reference: J375721A

Quality Systems Specialist

The main purpose of this position will be supporting manufacturing areas and all support departments. Interface with other Sites as appropriate and to ensure effective quality systems are implemented meeting industry standards and all cGMP requirements.

Job Requirements

  • Ensure all appropriate Quality Systems are in place for the site meeting cGMP , Corporate Standards and industry best practise.
  • Perform critical/constructive review of procedures on site.
  • Identify Improvements and Lead Projects to make step change improvements to site quality systems.
  • Actively contribute to continuous improvement initiatives at the site.
  • Conduct all activities in a safe manner and report all safety issues and/or concerns
  • Attends team meetings, regular 1:1's, support owns goals and team goals and actively manages own performance development.
  • Define, manage and maintain key metrics for Site Quality Systems ensuring site visibility, strong internal customer satisfaction and trending to support continuous improvement activities

Compliance Related Tasks

  • Mange E-Systems on Site as appropriate -TRACKWISE , Livelink, CATSWEB, Phenix and/or other electronic quality tools.
  • Co-ordinate all Complaints from customers and other sites ensuring they are appropriately logged, investigated, reported and trended ensuring collaboration with Regulatory and QP function.
  • Manage and continuously improve the Site Vendor Program incorporating Auditing, Complaint management, Quality Technical Agreement, Supplier File and Risk assessment where appropriate.
  • Manage, direct and support the Site Self Inspection Program (Internal Audit & Walkthrough Program)
  • Manage and improve the Site audit Readiness Program with cross functional ownership, effectively leading all external regulatory and corporate audits at Waterford.
  • Lead and direct change management on the site continuously gaining feedback for improvement.
  • Supporting and providing appropriate information to support Product Performance Reviews (PPR)
  • Ensure compliance to cGMP at all times

Experience

  • Third level qualification (degree in science or related discipline)or
  • Appropriate relevant experience supplementing lower grade scientific qualification
  • Minimum of 2/3 years' experience in a similar role
  • Pharmaceutical and oral dosage or sterile Manufacturing experience would be an advantage
  • Very good knowledge of cGMP in a regulated environment
  • Excellent accuracy and attention to detail
  • Strong Planning/Organising skill
  • Proven and effective Project Management skills
  • Customer Focus Driven with excellent interpersonal skills
  • Good Presentation skills
  • Working knowledge of computer systems
  • Personal development and goal management skills

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