QC Compliance Specialist

3 weeks ago

Waterford, Ireland Tandem Project Management Ltd. Full time

Summary:
A QC Compliance Specialist is required for a biopharmaceutical company in Waterford. The successful candidate will be responsible for Rarsing, managing and closing all quality system processes including assigned Change Controls, Deviations, CAPAs, ILIs & QEs.

Responsibilities:

  • Raising, management and on time closure of all quality system processes including assigned Change Controls, Deviations, CAPAs, ILIs & QEs.
  • Driving of all quality metrics for the department.
  • Forward review of Quality Metrics to ensure no over-dues.
  • Procedure effectiveness and simplification and actively contribute to continuous improvement initiative.
  • Ensure effective co-ordination and support for external and internal audits for the department.
  • Perform critical/constructive review of procedures and practices.
  • Identify and lead projects to make step change improvements to the department’s Quality.
  • Conduct duties in a safe manner and report all safety issues or concerns.
  • Support leadership team in achieving goals/tasks.
  • Actively contribute to continuous improvement initiatives utilising lean methodologies where appropriate.
  • Liaise with Quality Assurance Representative to support and improve RFT in the area and Always Audit Ready.
  • Ensure all required training is completed on time.
  • Maintain training in critical test activities as required in the laboratory (will be defined by head of QC).

Qualifications & Experience:

  • Bachelor’s Degree in Science/Engineering or equivalent.
  • Minimum of 2 years’ experience in a similar or related role.
  • Extensive knowledge of cGMP and GDP in a regulated environment.
  • Working knowledge of quality systems in a regulated environment.
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