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QA Specialist

  • Salary: Negotiable
  • Job type: Contract
  • Location: Dublin
  • Sector: Science
  • Date posted: 13/07/2017
  • Job reference: J368238A
This vacancy has now expired.

QA Process Specialist

We are currently seeking to recruit a Quality Assurance Specialist to join their QA Process Team on a temporary basis. Reporting to the QA Process Team Lead, the QA Process Specialist will be working closely with the business functions to provide QA support.

Responsibilities:

  • Review and approval of Manufacturing and Cleaning Batch Documentation and associated equipment logbooks in accordance with cGMP
  • Batch disposition and preparation of certificates of analysis
  • Pre-operative and routine inspections of the plants and facilities - shop floor presence.
  • Coordination of trend data for plants on a monthly basis
  • Participation in the internal audit team
  • Review and approval of GMP SOP's
  • Review of change controls
  • Participate in GMP reviews

Additional responsibilities:

  • Preparation of Campaign reports, Process Validation Reports, Process Verification Reports and Annual Product Reviews
  • 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
  • High level interaction with the various functions on site: Manufacturing, QA and Supply Chain

Requirements:

  • BSc or BEng in Chemistry or a science-related discipline
  • At least 2 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.
  • Excellent interaction, communication and presentation skills are necessary to be successful in the role.

Some experience in Operational Excellence or project management would also be advantageous.

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