Job Description
JOB DESCRIPTION
PositionQuality Assurance Assistant ManagerDepartmentQuality AssuranceImmediate SupervisorSite Plant DirectorCorporate Quality Assurance and Regulatory Affairs DirectorTop 3 things to know about this jobProgressive company Positive working environment and culture.Job security along with continuous training and developmentJob OutlineDutiesEffective management of the department to ensure high quality product is provided to customers in a timely manner Supervision of the Quality Assurance departmentEnsure site and all department's adherence to cGNfP and regulatory requirementsLiaison with the Corporate Quality Assurance Regulatory Affairs Director on matters related to the site Quality Management SystemCo-ordination of site activities related to audit preparation, lead during audits and follow-up as requiredCreation, review and approval of quality documentation such as master batch records and validation documentationTraining of other personnel and contractors in relation to site policy, quality and regulatory matters as required Maintenance and management of the Quality Management SystemEnsure the facilities equipment and instrumentation are maintained and operated under validated conditionsFinal release of materialCommunication with customers and regulatory authorities as requiredCooperation with other departments to achieve site objectivesOther duties as assigned by their supervisorResponsibilitiesTo 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 ensure investigations are performed in a timely manner and the implementation and follow-up of necessary actions as requiredTo 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 cGMP and to address any outstanding issue prior to releaseTo ensure that all material meets the relevant regulatory requirements, and all issues are resolved prior to approval and releaseTo lead site audit preparation and to act the site quality representative during audits To approve quality documentationTo ensure personnel are trained as per company policies and regulatory requirementsTo assist other department members issues as requiredJOB DESCRIPTIONTo ensure effective communication with customers and regulatory authorities as requiredTo perform periodic reviews of the QMS and its communication to site management and the Corporate Quality Assurance and Regulatory Affairs DirectorTo monitor company performance with respect to its manufacturing authorisations and reporting to the Plant Director and regulatory authorities as requiredTo have a general interest in quality assurance activities and the desire for improvement opportunitiesWorking ConditionsThis position is primarily an office-based role in the Quality Assurance with some duties performed within the GMP areas such as production, quality control and the warehouses and some supervisory duties. This position acts as the site lead for quality related matters and the liaison with the Corporate Quality Assurance and Regulatory Affairs Director and Regulatory Affairs department.The 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 and Regulatory Affairs Director and/or the Site Plant Director 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