Collins McNicholas

Role Responsibilities:

Drive a sustainable improvement in quality compliance on site by:

  • Daily production floor walkabout, on existing commercial and Creon 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  

Operations Batch Record Review:

  • Become trained in the batch record review process
  • Execute Batch record review in time of absence of holidays from batch review process.
  • 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

Human Excellence 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
  • Train operators on human error improvement

Data Integrity:

  • Support the close out of data integrity equipment issues on plant.
  • Participate in site data integrity plan as the operations team representative.

System:

  • Become an expert on Soltaqs, Attache, and Change control process in order to be able to implement changes

Role 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

 

For a confidential discussion and more information on the role, please contact Josh Barnes on 021-4911066 or email josh.barnes@collinsmcnicholas.ie

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