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QA Process Specialist

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Dublin
  • Sector: Quality & Compliance
  • Date posted: 12/04/2018
  • Job reference: J384585A

QA Process Specialist

SK biotek is seeking to recruit a Quality Assurance Specialist to join their QA Process Team on a permanent basis. Reporting to the QA Process Team Lead, the QA Process Specialist will be working closely with the business functions to provide QA support.

Key responsibilities:

  • Support all quality related operational activities prior to and during a manufacturing campaign.
  • Preparation of Process Validation Reports and Annual Product Reviews.
  • Pre-operative and routine inspections of the plants and facilities.
  • Participation in the site investigation process supporting the identification of root cause and appropriate corrective actions
  • Participate in audits by customers and regulatory agencies
  • Review of change controls
  • Support implementation of Lean QA initiatives - critically evaluate current processes and continually identify efficiencies and compliance requirements

Additional responsibilities:

  • Preparation, update and delivery of training including preparation of courses and assessments
  • Compilation of Process and Cleaning validation protocols and reports.
  • Communicate with all departments on site on a regular basis to ensure timely approval, use and shipping of product
  • Interaction with the various functions on site: Manufacturing, Manufacturing Science & Technology and Supply Chain

Education & Experience

  • The successful candidate will hold a BSc or BEng in Chemistry or a science-related discipline
  • 3 years pharmaceutical experience ideally in a QA role.
  • The successful role holder will be able to demonstrate excellent time management and organisational skills along with a proven ability to multi-task.

The QA Process Specialist will be required to work on his/her own initiative as much as working as part of a team. As such excellent interaction, communication and presentation skills are necessary to be successful in the role.

For more information on this vacancy please contact Darragh on