QA Specialist. Reporting to: QA Manager. Company: multinational manufacturing company. Location: Galway. The Role. Support Annual Reports submission, Product Development and Product Launch. Review of stability data. Support the Sites in investigating laboratory OOSs. Support of Investigation of product complaints, OOS and non-conformances of Affiliate Sites & Associated Vendors. Review of Product Quality Review Reports. Provide Technical Transfer and Process Validation Support. Review equipment, process, method validation protocols and reports, and stability protocols and reports. Review of Technical Agreements and Confidentiality Agreements. Provide training to Regional QA staff & QA Affiliate staff at the relevant manufacturing & packaging site in GMP practices and procedures when required. Criteria for the position: Minimum of a Bachelor's degree (or equivalent) in science or pharmacy. 5+ years of experience in quality control or quality assurance within a GMP environment. Must possess knowledge and experience of all quality system aspects including: Deviation management, CAPA, Complaint handling, auditing, change management, supplier qualification, and batch release. Experience in troubleshooting within a QC laboratory background is desirable. Knowledge of Validation and Aseptic manufacturing an advantage but not essential. Knowledge of Pharmaceutical QMS Systems and of Quality Risk Management Systems. Knowledge of cGMPS i.e., USFDA, 2003/94/EC, MHRA and WHO. Knowledge and experience in the use of Data Sharing Software Packages an advantage. Periodic travel may be required. Interested candidates please contact Annette Murphy on 091 507515 or email your CV in confidence to email@example.com. This job originally appeared on RecruitIreland.com.
187 days ago