- 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
- 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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