Job Title: Quality Technician
Location: Hay on Wye
Department: Quality Assurance
Reporting to: QA Technical Manager, Principle Quality Technician
Responsible for (staff): N/A
General Purpose of Role:
- An opportunity has arisen for a Quality Technician to join the Quality Technical team. The successful candidate will provide assurance of the quality of the packaging process by audits and inspection processes. They will provide support and training to the production group.
- The successful candidate will have good communication skills along with the ability to identify and solve problems. The ability to produce relevant documentation is also required
- Inspection of packing lines before materials are introduced to ensure freedom from materials from a previous operation and the equipment has been cleaned as per the relevant SOP.
- Carry out in-process checks on Clinical Trials as specified in the CT packaging instruction.
- Perform documentation audits of cubicles; including challenges, in-process records, line clearances, end of line inspection and overall documentation completion and accuracy to increase RFT, working actively with the production team to resolve any issues which have been identified.
- Perform housekeeping inspections of cubicles including for example spot checks of log books, SOP’s and training records; actively working with the relevant departments to resolve any issues which have been identified.
- Advising the Principal Quality Technician of any abnormality observed with a product, component or finished product found during inspection. Escalation to the Quality Technical Manager if required.
- Ensure that all scales, leak test equipment used within the production environment is calibrated and maintained.
- Checking of clinical trial and commercial labels for accuracy.
- Supporting training and competency assessment, of production and quality personnel, including challenges, in-process checks and booking in/verification of materials; maintaining the training matrix and quality assessment records for each individual.
- Start initial investigation and generate Exceptions relating to trending issues highlighted within quality audits and IPC’s.
- Carry out complaint investigations.
- A technical or vocational qualification equivalent to an NVQ level 2
Previous Work Experience:
- Relevant experience within GMP or similar environment.
- Experience of working to quality standards.
Specific Knowledge / Skills Competence:
- Relevant knowledge of quality related procedures & documentation.
- Understanding of GMP and the Quality Assurance role within GMP.
- Ability to produce relevant documentation to the required standards.
- Ability to train and develop others
- Good IT skills (Microsoft Office)
- Good communication skills
- Ability to identify and solve problems
- Decision making skills
- Flexible within working patterns
- Ability to work unsupervised.
- Ability to influence others.