Quality Manager (Pharma)
Quality Manager (Pharma) - County Waterford. Key accountablities: To manage the compliance within the department and ensure that the area is operating in accordance to GLP. To provide support on any external investigations. To lead continuous improvement activities and support projects. Assist in any validation activities that may be required as the Quality representative within the project. To oversee the product and process performance using appropriate metrics Quality representative on the sign-off of change controls, documentation and validation activities. Lead projects for the introduction of new equipment within the site, ensuring that the correct level of validation is completed, that the relevant procedures are updated, and that there is a training plan in place. To approve all reports generated due to any investigational work that is requested due to a complaint or a potential issue within the manufacturing site. To ensure that the data generated is accurate and generated in a timely manner to help close out issues and potentially release product. To ensure that the procedures are up to date and in compliance with the global systems. To ensure that the records generated are accurate and completed in real time. To review method validation protocols and reports on new/ existing test methods, as required. Applicant Requirements: Experience of scientific report writing including such documents, protocols, deviations, reports etc. Will have managed a QA department for at least 5 years in pharmaceuticals. Have the ability to evaluate and assess information to determine appropriate and required actions is critical. Good knowledge of tablet manufacturing desirable. Knowledge of purified water and Environmental Monitoring systems. Full understanding of the requirements of the Regulatory Standards. Degree in chemistry, science or related technical discipline. This job originally appeared on RecruitIreland.com.
340 days ago