Job Description
PositionQuality Assurance SpecialistDepartmentQuality AssuranceImmediate SupervisorQuality Assurance Assistant Manager (or designee in their absence)Top 3 things to know about this jobProgressive company Positive working environment and culture.Job security along with continuous training and developmentJob OutlineDutiesMaintenance of the Quality Management System (QMS) and the use of its associated software (Pragma and Adhoc)Review of manufacturing and cleaning recordsReview of shipment documentation and containers prior to releaseIssuance of materials to productionPerformance of the Good Manufacturing Practice (GMP) Walkthroughs as scheduledProvision of proactive reporting, investigation and response to quality related issuesLiaison with the Quality Assurance Assistant Manager on matters such as those related to the QMS, audits, documentation, etcPreparation of quality documentation such as product quality reviewsPerformance of cleaning visual inspectionsProvision of training to others as requiredProvision of assistance with audit preparation and the performance of internal audits as requiredProvision support to other departments for quality related issues and to the Quality Assurance Assistant Manager to ensure site adherence to current GMPPerform other duties as assigned by their supervisor (or designee in their absence)ResponsibilitiesTo adhere to cGMP and EHS practices at all timesTo liaise with supervisors to ensure the rapid communication of issues and the progression of projects, material release, etc.To ensure the QMS is maintained as per cGMP including but not limited to change controls, deviations, corrective and preventative actions, controlled documentation, etc.To prepare quality documentation including but not limited to product quality reviews, quality risk assessments, etc. To critically review and approve updated documentation as requiredTo critically review manufacturing, cleaning and shipment documentation to ensure their adherence to cGlv1P and to address any outstanding issue prior to releaseTo ensure that all material meets the relevant requirements, and all issues are resolved prior to approval and releaseTo support the Quality Assurance Assistant Manager with audit preparation and to participate in audits To assist other department members issues as requiredTo assist with periodic reviews of the QMS and its communication to site management and the Corporate QualityAssurance and Regulatory Affairs DirectorTo have a general interest in quality assurance activities and the desire for improvement opportunitiesJOB DESCRIPTIONTo act as a designee for the Quality Assurance Assistant Manager in their absence if no Quality Assurance Supervisor is presentWorking ConditionsThis position is primarily an office-based role in the Quality Assurance with some duties performed within the GVW areas such as production, quality control and the warehousesThe company will provide workplace conditions in which its personnel can function safely and efficiently. All personnel are required to comply with current standard operating procedures and cGMP as required.Work PerformanceThe employee's performance will be monitored by the Quality Assurance Assistant Manager and will be assessed as per the following criteria:General timekeeping and attendanceWork outputQuality of workmanshipCompliance with agreed work schedule and programmeCompliance with Health, Safety and Environmental and Quality practicesAbility to work in a team environmentAbility to work independentlyWork attitudeTraining and self-developmentContribution to improving the departmentOverall team performanceNext Steps Click apply to start the process today or reach out to Conor O'Hagan at Hunter Savage for further information