QA Rep Systems & Compliance

Posted 22 December 2020
SalaryNegotiable
Location
Job type Permanent
DisciplineLife Sciences & Engineering Technologies, Science Leaders & Specialists
ReferenceBBBH28239_1608639002
ContactPaul Wheatley

Job description

Our client is a globally leading pharmaceutical company whose innovative medicines continue to benefit millions of people all over the world. They are seeking an experienced QA Representative to join their Quality Assurance team. The role will be based in their manufacturing site in Cork.

The Position:

  • QA Business Process Owner for Deviation, Change Management, Activity planning and Trend Management and Owns these SOPs.
  • Review and approval of key GMP documents such as GMP standard operating procedures.
  • Day to day running of the TrackWise Review Board (TRB).
  • Coordinates TRB Governance.
  • Reviews all deviations and L3 changes.
  • Generates the weekly, monthly and quarterly metrics for deviations and change controls.
  • Promotes a culture of continuous improvement.
  • Monitoring of GMP compliance, GMP programs and systems.
  • Coordinates Site Self-Inspection program.
  • Coordinates RCI Facilitator group.
  • Reports and escalates critical quality issues to the appropriate level of quality management for final resolution.

The Person:

  • BSc, MSc, or PhD in Chemistry, Engineering or related discipline.
  • 2 years' experience in a similar role.

To learn more about this role apply online or contact Paul Wheatley on +353 873449559 for a confidential discussion.