This position reports to the Quality Assurance Supervisor, Production. The Quality Inspector is responsible for process monitoring and auditing of packaging operations, the duties including real-time batch documentation review, monitoring of adherence to cGMP, training on cGMP where necessary, managing deviations and investigations to resolution and completion. The scope of work will cover packaging room and equipment set up, equipment verification, routine packaging operations, line clearances, room and equipment cleaning activities. The Quality Inspector will identify opportunities to improve the ‘right-first-time' performance of the operation and will manage those opportunities to implementation and improvement, in partnership with Production personnel.
III. Specific Duties, Activities, and Responsibilities:
- Responsible for ensuring that Standard Operating Procedures are consistently followed and that cGMP's are observed, in the course of packaging operations. This may require the simultaneous auditing and/or monitoring of one or more operations.
- Verifies and reconciles materials to and from Clinical Production rooms and works accordingly with Production, Materials Management and Project Management to handle any possible discrepancies.
- Inspects and releases all clinical packaging rooms to ensure that they have been properly cleaned and that all materials have been removed. Documents all activities accordingly in the associated logbook.
- Supports and assists Mechanics on the execution of Operational Verifications (OVs) and Set-Up Records (SURs) both prior to the start and during the process (if necessary) for any jobs using validated or non-validated equipment respectively.
- Reviews and understands both the Production Protocol and QA Protocol prior to starting the Clinical Packaging process.
- Performs and documents hourly QA Inspections on assigned clinical packaging rooms as per both the QA Protocol and SOPs requirements as well as ensuring that the Production Protocol and GMP standards are being followed.
- Reviews the batch record and any associated paperwork for any documentation errors made during the clinical packing operation and again when the job is completed prior to submitting the batch record to document control.
- Reviews EMS system printouts for out of specification temperatures, humidity and pressures.
- Prints and reviews Material Usage Reports for each clinical packaging job and/or operation to ensure that the drug product quantities documented in the batch record match those that are entered in the Inventory Management System.
- Ensures that all Inventory Management System printed labels are correct against the information provided in the associated protocol.
- Updates the daily/shift QA turnover log with all pertinent information regarding activities during the assigned rooms and shifts and forwards relevant notes via email to all pertinent employees.
- Performs walk through audits of the production floor, clean storage rooms, warehouse and associated areas to ensure cGMPs are being followed.
- Reviews production logbooks for GMP compliance as each operation is completed and revises SOPs as needed.
- Partners with other departments in resolving unplanned deviations, investigations and in troubleshooting. Drives deviations and investigations to completion...cont.