Collins McNicholas

Role Responsibilities:

  • To support the Quality Assurance Manager and Quality Assurance Team lead with the quality assurance function relating to packaging operations.
  • 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.
  • Implement and maintain the company Vendor Qualification Programme.
  • Review and approve batch related documentation as required.
  • Generation and approval of SOPs.
  • Organisation internal (self-inspections) and external QA auditor.
  • Liaise with packaging operations / laboratory personnel to ensure regulatory and quality requirements are met.
  • Assist with preparation of Submission Documentation in support of license applications and customer requirements.
  • Noncompliance reporting and corrective action / continuous improvement implementation.
  • Operation of company SAP (ERP System) Quality function as per procedures
  • Support the on-going OOS/OOT/ Deviation/CAPA 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

 

Role Requirements:

  • A third level degree incorporating Quality Assurance/ management
  • Ideally 3 years Quality Assurance experience in a pharmaceutical packaging environment.
  • Experience in packaging validation, Line clearance, Material reconciliation, packaging specifications, control of Artworks
  • Experience in Serialization implementation and execution.
  • Experience in managing customer and supplier complaints.
  • Lead auditor training complete
  • Internal audit experience
  • Experience with facilitating customer audits
  • Careful planning to achieve accurate and timely results to support the packaging plan.
  • Ability to define and manage own tasks and schedules

 

Skills Required:

  • Multi-tasking, ability to achieve deadlines
  • Strong compliance
  • Computer Skills to include MS office
  • Proven time management skills
  • Planning & organizing
  • Familiarity with cGMPs relating to pharmaceutical manufacturing
  • Working knowledge of EDMS (Electronic Document Management System) and ERP (Enterprise Resource Planning)
  • Good attention to detail

  

For a confidential discussion and more information on the role, please contact Josh Barnes on 021-4911066 or email josh.barnes@collinsmcnicholas.ie

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