Description:
Performs activities related to the support of all established quality system, product release cGMP
compliance requirements in the assigned area of the facility.
Conduct process monitoring and support adherence to quality standards of products, processes and areas.
Principal Responsibilities
Key Responsibilities:
Key responsibilities will include (but are not limited to) the following:
- Shift Quality Technician on a front line manufacturing team delivering on customer focused quality decisions in real time. Ensure effective and efficient handover to rotating shift team members.
- Ensure adherence to quality plans and conduct final review of batch documentation, including release of product on the MIS system.
- Supports selection of Product for testing and ensure that the associated documentation is completed to the required standard. Tracking interactions with external test facilities for timely completion of prescribed tests.
- Where applicable Compile and review and signoff of sterile product batch records for routine commercial sterile product loads, Including all prescribed testing. eg residual data, Bioburden, LAL and cycle conditions.
- Monitoring of area housekeeping programmes, to ensure standards are maintained and records are completed and compliant.
- Develop, implement and monitor visual standards to meet agreed Customers specifications.
Professional Skills/knowledge
Education / Experience Requirements
- Diploma in Quality/Engineering / Science or equivalent qualification.
- Min 4 year industry experience in a medical device manufacturing environment or similar.
- Knowledge of quality principles and ability to utilise these in a manufacturing environment.
- Excellent attention to detail and GDP.
- Experience within a hands on line support type role is highly desirable.
- Good understanding of problem solving and statistical methodologies is required. Yellow belt level desirable.
- Excellent Computer Skills (Word, Excel and PowerPoint).
- Excellent communication (both verbal and written) & interpersonal skills.