Senior Quality Assurance Officer

ICDS Recruitment

Waterford

Senior Quality Assurance Officer. Job description. Responsibilities: To support the Quality Assurance Manager and Quality Assurance Team Lead with the quality assurance function. Electronic Documentation Management System - QUMAS Check own work and that of others for accuracy before / prior to ‘QA Authorisation’ of documentation. QA reviewer of Process Compliance Change Controls. To ensure that all work carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines. Review batch packs for QA/ QP release. Review batch related documentation as required. internal audits (self-inspections. Liaise with operations / laboratory personnel to ensure regulatory and quality requirements are met. Assist with review of Submission Documentation in support of license applications and customer requirements. Noncompliance reporting and corrective action / continuous improvement implementation. Operation of SAP (ERP System) Quality function as per procedures. Support the on-going OOS/IR/CACI closeout programme. To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement. Check own work and that of others for accuracy. To assist in the preparation for customer/ regulatory inspections. Attend a number of cross functional team meetings as a Quality Assurance representative. To perform additional team tasks as agreed to support effective running of the Business. Compile and deliver quality based training with the company. Health & Safety. Implement safety requirements as per site documentation including SOPs, Safety Statement and COPs. Report any hazards. This job originally appeared on RecruitIreland.com.

2578 days ago