Quality Compliance Engineer

  • Cork
  • Permanent
  • JO-1903-64316_1552307659

Summary

Responsibilities:

    • Daily production floor walk about, on existing commercial facilities, observing and engaging with production staff on GMP standards.
    • Feedback to supervisors on observations made and track closure of items.
    • Trends observations and publish compliance metrics weekly for shift supervisors
    • Develop and lead the implementation of Operations Compliance Programme
    • Has a strong interaction with the Quality Compliance team
    • Develop and track operations compliance facility improvement plan with engineering
    • Train operators on compliance improvement
    • Become trained in the batch record review process
    • Execute Batch record review in time of absence of holidays from batch review process. (estimated at 10% of the time) or required
    • Review the comments process during Batch Review from an operations perspective and develop a programme to reduce the number of comments, through Batch record update or reporting of key similar repetitive issues.
    • Has a strong interaction with the Quality Assurance Specialist Team
    • Train operations on GDP improvement
    • Become trained in Human Error analysis
    • Work with Supervisors during human error events to ensure consistent application of human error cause codes
    • Develop sustainable CAPA for each human error non-conformance report.
    • Trend Human Error cause codes and develop key themes for the elimination and reductions of Human Error.
    • Be the operation lead for the Human Excellence Project Virtus on site, this may also mean participating in the Global team.
    • Train operators on human error improvement
    • Support the close out of data integrity equipment issues on plant.
    • Participate in site data integrity plan as the operations team representative.
    • Become an expert on Change control process in order to be able to implement changes

Requirements:

  • A minimum of 2 years' experience working in operational or quality role within a production manufacturing environment
  • Must have excellent written and verbal communication skills
  • Work as part of a team and have good presentation skills
  • Experience of identifying and implementing projects to improve production process/business process efficiencies.
  • Proven Track Record working in a continuous improvement environment using concepts such as Lean Manufacturing and Six Sigma
  • Expert working knowledge of Soltaqs

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