QA Specialist - Athlone
Pe Global
Athlone, Westmeath
PE Global are currently recruiting for a QA Specialist for a client site in Athlone - Principal Responsibilities. Site QA responsibility to provide technical expertise for all QA and compliance topics / issues relating to manufacturing and product supply. Acts as quality point person, providing guidance and feedback on quality assurance issues. Performs timely review of documentation/investigations/reports highlighting and assisting in the resolution of issues commensurate with the level of risk. Ensures schedules for review and approval of GMP documents are maintained to meet the needs of Clinical and Commercial Operations groups. Provide sound QA and Compliance support to manufacturing, engineering, utilities, supply chain and material movement (including cold chain) for both clinical and commercial products. Ensure relevant QA documents and procedures are approved to schedule to support technology (external and internal) transfers and new product introductions. Provide support for deviation investigations, including root cause analysis, and corrective & preventative action (CAPAs) proposals and initiatives. Deliver Quality Assurance review and approval of SOPs, master batch records, policies, operational standards, validation protocols and reports as required. Actively contributes to continuous improvement activities. Qualifications. Min 3 years QA experience in a pharmaceutical manufacturing environment, preferably in a biopharmaceutical environment. An ability to work independently, as well as a member of a team in a dynamic, fast-paced environment. Excellent communication & presentation skills are essential. Excellent time management organizational skills along with a proven ability to multi-task. Education. B.Sc. in science/engineering with a minimum of 3-5 years’ experience in cGMP Quality environment; or equivalent combination of education and experience. Interested Candidates should send their CV to Audrey.brennan@peglobal.net or call 0214297900. This job originally appeared on RecruitIreland.com.
2229 days ago