For our client, we are looking for the following professional profile:
Author, revise and review SOPs and the other documents required to develop and maintain the Quality Management System.
Provide training to the personnel on the Quality Management Systems.
Manage internal and external auditing programs. Conduct GMP audits of internal departments, contract-manufacturing organizations, outside testing laboratories, and other outside providers.
Primary company interface during the authority and custom GMP inspections.
Manage vendor qualification program.
Lead batch disposition activities. Review of Batch Records and Laboratory Test Records and generation of documents needed for release e.g. COA, Compliance Statement, Release Notification, etc.
Lead investigations and CAPA program. Work with cross-functional teams to investigate quality events (deviations and quality incidents), CAPA implementation, closures and evaluate CAPA effectiveness.
Perform trend analysis of Quality Event, internal and external audit finding and generate trend reports. Report trends identified to Quality Management and recommend CAPA and improvements to eliminate or decrease the risk/impact associated with the trends.
Lead or be part of the quality team that is managing the manufacturing and testing facility commissioning, including facility validation, and equipment validation.
At least 5 years of Quality Assurance experience in regulated industry (pharma/biotech) in a full GMP environment.
Ticinonline SA opera tramite il portale Internet Tuttojob.ch con regolare autorizzazione del Canton Ticino per il collocamento privato di posti di lavoro rilasciata in data 10 gennaio 2017 dall'Ufficio giuridico della Sezione del Lavoro.