Quality Assurance Executive
Collins Mcnicholas Recruitment
Galway
My client a global generic and specialty pharmaceuticals company located in Co. Galway is looking for Quality Assurance Executive III. Resposibilities: Maintenance of the incident report system (unplanned deviations), supplier non-conformance system and the CAPA system. Manage the internal audit program. Manage Customer Quality Complaints/Medical Device Vigilance systems. Manage the company’s GMP training program. Manage the company’s routine commercial stability program. Prepare monthly/quarterly/annual KPI/Management review data and annual product quality review reports. Perform detailed batch record review of finished products prior to QP/QA release. Deputise for the QA Team Leader if required. Qualifications: Minimum of a Bachelor's degree (or equivalent) in a Science related discipline and 5-8 years relevant experience within a pharmaceutical company with a minimum of 2 years’ experience within a Quality Assurance role. Experience of sterile manufacturing desirable but not essential. Experience of all quality system aspects including: Deviation management, CAPA, complaint handling, auditing, change management, supplier qualification, and batch release. Experience of TrackWise or similar electronic document management systems is highly desirable. Excellent communication (oral & written) and presentation skills. Ability to handle multiple tasks in a fast-paced environment with strong organisational and time management skills. Experience of working with various IT systems and software packages with strong working knowledge of Microsoft Office (Word, Excel, PowerPoint etc.) Proficiency in speaking, comprehending, reading and writing English is required. ******************************************************************************* For a confidential discussion and more information on the role, please contact Edyta Fleming on 091706721 or emailedyta.fleming@collinsmcnicholas.ie. This job originally appeared on RecruitIreland.com.
2070 days ago