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In Process Quality Assurance Specialist

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Tipperary
  • Sector: Science
  • Date posted: 26/07/2017
  • Job reference: J371170A

In-process QA

An IPQA (In-process QA) is required to join a leading pharmaceutical manufacturing company. Reporting to the QA Lead, the IPQA 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, 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 of interaction with the various functions on site: Manufacturing, QA and Supply Chain

Qualifications/Experience:

  • The successful candidate will hold a Diploma in Quality Systems or a science related discipline
  • At least 2 years pharmaceutical, ideally in an IPQA role, or an Inspections role within Operations.
  • The successful role holder will be able to demonstrate excellent time management and organisational skills along with a proven ability to multi-task.
  • The IPQA 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.
  • Some experience in continuous improvement activities and project management would also be advantageous.

For more information please contact Kathryn on 016455250 or email

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