Quality Assurance Executive
Are you an experienced Quality Assurance professional based in the West? Are you looking for your next role? I have a Maternity cover contract available with a leading multinational employer in Galway. Starting in February you`ll join a high performing and tight knit Quality team overseeing the quality activities of Third Party manufacturers. If you have a Degree in Life Sciences or Pharmacy along with 3 or more years of experience in a QA or QC role this could be the next step in your career. Main Duties: • Support release of Third Party Manufactured (TPM) products, by review of batch documentation. • Review Third Party Manufacturer’s Deviations and Incident Reports. • Prepare and assess Change Control documentation from Third Party Manufacturer’s. • Support Annual Report submissions for Third Party Manufacturer’s. • Prepare Annual Product Quality Reviews for Third Party Manufactured Products. • Review and approval of artwork change controls. • Review stability protocols and reports from TPMS’s. • Performing Third Party Manufacturer and API supplier risk assessments. • Support the Management of the Vendor Approval System. • Preparation of SOP’s, Technical Agreements and Confidentiality Agreements. • Maintenance of Product Technical Files. Here are the minimum qualifications and essential functions for this position: • Minimum of a Bachelor`s degree (or equivalent) in a life science or pharmacy and 3-5 years of experience in quality control or quality assurance within a pharmaceutical company. • Experience of sterile injectable manufacturing and supplier quality management desirable but not essential. • Knowledge of Pharmaceutical QMS Systems. • Knowledge of Quality Risk Management Systems. • Knowledge of cGMPS i.e., USFDA, 2003/94/EC, ICH Q7 and WHO. • Knowledge and experience in the use of Data Sharing Software Packages an advantage. For more on the role call Nigel on 021 4221000 or send your CV for consideration. This job originally appeared on RecruitIreland.com.
383 days ago