Provide documentation review/approvals supporting external and internal teams to provide a high degree of assurance that sterile drug product programs will achieve regulatory approval, clinical release, and commercialization.
Lead collection of internal and external quality metrics which includes tracking, trending, and escalation of issues; review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness.
Overseeing laboratory technicians in performing wet chemical, instrumental, microbiological and physical analyses of in-process, intermediates and finished goods, raw materials, water and waste treatment samples.
Responsible for the consistent and correct execution of QS global procedures within the site to ensure the quality and compliance of processes and records for Change Control, Records Management, CAPA, NC, Customer Complaints Investigations, QPR and QSMR and Filed Action Investigations.
The Quality Engineering Manager will be the functional expert of the Quality Engineers and Quality Inspectors. The Quality Engineering Manager will lead, identify, and implement the Morgan quality system at the factory and corporate level using lean techniques for quality improvement. The role will identify best practices, processes, and standard work for the integration into Morgans quality / manufacturing strategy to ensure consistent high quality results.
This role will specifically include evaluation of portfolio processes and change management activities across the Bank while offering guidance on where and how improvements can be made, including recommendations on key controls, performance metrics, and governance needs for monitoring the change management capability.
Oversees all requests for procedural documents related to health authority inspections and internal audits. Provides local coverage for responding to urgent requests in a timely manner, retrieving procedural documents from the EDMS. Performs technical review of procedural documents, ensuring use of appropriate templates and formatting.
The QA Manager is responsible for the quality management of vendors and contractors to ensure regulatory compliance of manufacturing, testing, packaging, and release activities of Contract Manufacturing Organizations (CMO's).