QA Executive - Galway

Collins Mcnicholas Recruitment

Galway

Reporting to the Senior Manager Quality Operations Injectable, the Quality Assurance Executive position will support complaints/escalations/FARs investigations, PQR review and batch records review of products manufactured/ packaged by my client's Affiliate Injectable sites. Responsibilities: Investigation of product complaints of affiliate sites & associated vendors and of third parties. Support the affiliate sites in investigations related to escalations (such as but not limited to OOT / OOS laboratory investigations, process deviations. When applicable, file FAR in timely manner and investigate the reported defect. Review of Product Quality Review (PQR) Reports for affiliate injectable sites. Preparation and review of SOPs. Preparation of monthly/quarterly/annual KPI/Management review data as required. Provide training to QA Regional staff & QA Affiliate staff at the relevant manufacturing & packaging site in GMP practices and procedures. Liaise with Clinical, Manufacturing and Packaging sites as required. Support other activities of the Regional Quality team such as but not limited to : Batch records review. Deviations review. Product technical files. Continuous improvement tasks / projects. Preparation and control of Technical Agreements and Confidentiality Agreements. Support Annual Reports submission, Product Development and Product Launch for Injectable Affiliate Sites. Support Affiliates Injectable sites inspections if required. Provide technical transfer and process validation support. Review equipment, process, method validation protocols and reports. Review of stability data, stability protocols, stability reports for affiliate Injectable sites. Perform other duties as assigned. Skills, Experience and Qualifications: 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/ medical device company. Experience of sterile injectable manufacturing and third party/affiliate site quality management desirable but not essential. Experience with QC/Manufacturing Deviations. Experience with Regulatory Bodies. Quality QA and/or QC experience working in a pharmaceutical GMP environment. Experience in QA operational and compliance issues – investigations, complaints, batch review, deviations etc. QC experience is an advantage in OOT / OOS / analytical investigations. A knowledge of Trackwise software is an advantage. As this role supports affiliate injectable sites, an experience in third party manufacturing oversight and/or sterile manufacture is ideally required. For a confidential discussion and more information on the role/company please email your CV to: amy.oneill@collinsmcnicholas.ie. This job originally appeared on RecruitIreland.com.

2500 days ago