QA Specialist

Fastnet The Talent Group

Cork

Responsibilities. Approve and close out of OOS/OOE and laboratory deviation investigations and actions. Monitor, progress and follow up corrective actions and preventative actions. Assess events and their root causes, ensuring appropriate corrective and preventative actions. Period review of quality related KPIs. Provide guidance to QC on cGMP relevant queries. Participate in root cause investigations. Prepare and deliver general quality related training programs. Update/approve documents to ensure compliance with cGMP. Perform internal audits and gap analyses. Participate in internal/external audits. Review all documentation including COAs, OOS deviations prior to batch release. Making final decision on appropriate status for APIs and disposition appropriately. Requirements: BSc in Chemistry or relevant area. Experience working with CMO's would be ideal. 3 years' experience working in the pharmaceutical industry within QA. Excellent communication Skills. Ability to work on own initiative. Ability to positively influence. Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent. Fastnet - The Talent Group. 'Not Just Placers.........Partners' The Life Science Specialists. This job originally appeared on RecruitIreland.com.

2447 days ago