QA Visual Inspector
T: + 44 (0)28 3026 4435
To provide independent QA oversight of the Vial Inspection Area and to ensure activities within the Vial Inspection Area are compliant with in-house procedures and GMP standards. To ensure that AQL sampling and inspection is conducted on every batch processed through the Vial Inspection Area in accordance with in-house procedures. Responsible for the training program to qualify staff as vial Inspectors.
- To calculate the AQL sample size and conduct the necessary inspection of the required sample size.
- To ensure all documentation completed during conduct of role as an QA/AQL Visual Inspector is conducted in accordance with Good Documentation practices.
- Ensure all equipment associated with Qualification and AQL inspection is maintained to the required standards and suitably calibrated.
- The AQL Visual Inspector should always ensure that they are trained to conduct the function in accordance with in-house procedures.
- To have a comprehensive knowledge and understanding of SOPs applicable to the area and to participate in the review and update of procedures as and when required.
- To supervise the activities within the Vial Inspection area to ensure they are aligned to the standards outlined in the relevant procedures and ensure deviations are raised as and when required.
- Ensure all personnel required to operate as AQL Visual Inspectors or 100% Visual Inspectors are qualified according to in house requirements and perform qualification/re-qualifications as and when necessary.
- Ensure a QA review of the Vial Inspection documentation pack is conducted and corrective actions undertaken when required in a timely manner prior to submission to the batch release team.
- Conduct trending of defects and AQL failures, ensuring the necessary corrective action is taken to address adverse trends and approve the relevant documentation.
- Ensure Deviations/CAPAS and NCRS applicable to the AQL area are addressed in a timely manner.
- Reporting through the QA Department, you will have the responsibility to approve and control the issuing of Working Copy Documents for the recording of data within the GMP environment
- Any other duties as deemed necessary by Management.
- Successful candidate will be educated to a minimum of GCSE level or equivalent with passes in English and Maths Grade A-C
- Working Knowledge of cGMP and cGDP requirements within the pharmaceutical industry.
- Ability to read and understand written instructions.
- Ability to work on their own initiative.
- Ability to prioritise their own workload to ensure department targets are met.
- Have the ability to communicate effectively across a chosen range of inter-departmental levels.
- Ability to work a shift pattern.
- Previous experience of quality assurance including but not limited to AQL inspections.
- Previous Experience of Packaging/production operations.
- Good Knowledge of Quality Standards
Norbrook Laboratories Limited employs a workforce with members of all sections of the community and is committed to appointing people purely on the basis of merit. In accordance with our equal opportunities policy, we would particularly like to welcome applicants from the Protestant Community.