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Employer CPL
Job Title Quality Assurance Specialist QP
Description

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
Location Ahtlone, Westmeath
Date Added 14 days ago
Apply Link
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