QA Process Specialist

  • Location

    Dublin North, Dublin

  • Sector:

    Science

  • Job type:

    Permanent

  • Salary:

    Up to €1 per annum

  • Contact:

    Jack Conway-Kenny

  • Contact email:

    jack.conway-kenny@experis.ie

  • Job ref:

    BBBH96597_1553090235

  • Published:

    about 1 month ago

  • Expiry date:

    2019-04-19


QA Process Specialist

My client, a Global Leader in the Pharmaceutical market is looking to recruit a Quality Assurance Process Specialist to join their QA Team on a permanent basis. Reporting to the QA Team Lead, the QA Process Specialist will be working closely with the business functions to provide QA support.


Key Responsibilities

  • Ensure all quality systems are implemented / executed in compliance with ICH Q7 and site quality standards.
  • 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.
  • Review and approval of GMP SOP's, change controls and deviations.
  • Participate in customer and regulatory inspections:
  • Preparation of Campaign reports, Process Validation Reports, Process Verification Reports and Annual Product Reviews
  • 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
  • Support the introduction of New Products to site.



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. The QA Specialist will be committed to;

  • Continuous improvement projects
  • Leading initiatives and working with members of the Value Stream to drive efficiencies and to assure compliance standards for the site.



Education/Experience
The successful candidate will hold a BSc or BEng in Chemistry or a science-related discipline, and should have at least 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.

Interested in a move in 2019?
Call Jack on 01-6455250, or send on your CV to jack.conway-kenny AT experis.ie and I'll get back to you!