Quality Assurance Specialist QP

CPL

Ahtlone, Westmeath

My client is a Global Pharmaceuticals company and a publicly traded, clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with glaucoma and other diseases of the eye. In conjunction with the CPL Group they are looking to set up a new start-up manufacturing facility and are looking to recruit for a Quality Assurance Specialist for its new facility based in Athlone. Responsibilities: Works with manufacturing, technical and other quality colleagues as part of a team whose shared goal is to realise the safety, quality, delivery and cost objectives of the site. Manages the Change Request System, Deviation System, CAPA System and provide Monthly KPI on such. Assist in the management of Customer Quality Complaints & Pharmacovigilance systems. Perform detailed batch record review of finished products prior to / for QP release. Assist in the management of the routine commercial stability program. Prepare annual product quality review reports. Assist in the maintenance of the company incoming inspection program. Assist in the management of the internal, vendor and regulatory audit program including the performance of audits as required. Maintain & control QA documentation issue numbering indices, databases, and control logs. Issuance of batch record paperwork to the relevant manufacturing responsible and to manage issuing, distribution and withdrawal of SOPs and associated documents. Education and Skills Degree in a Science or Engineering related discipline. 5+ years’ experience working with in a GMP Environment. 3+ years’ experience working with an GMP Deviation System. Experience in managing a Deviation, CAPA and Change Request System, ensuring all changes are evaluated and approved by the key approvers and stakeholders. Experience in a regulated GMP environment and familiarity with the associated terminology and work flow. Experience in Risk Analysis and Mitigation Techniques. Experience in batch record review. Experience in the performance of GMP Audits to include vendor and internal audits. Experience working with an GMP: CAPA/ Deviation and Document Management Systems preferably Veena Doc Control / QMS Systems or alternatively Q-Pulse or Trackwise type systems. Experience in participation in GMP Regulatory body audits e.g. FDA, HPRA or equivalent. Qualified Person Status. Suitable applicants should email their cv to aileen.cahill@cpl.ie or call me on 01-6146007 for a confidential conversation today. This job originally appeared on RecruitIreland.com.

2305 days ago