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Employer Fastnet The Talent Group
Job Title QA Officer - Gdp
Description

Responsibilities

  • Responsible for providing support in the maintenance and improvement of the local Quality Management System. Supporting the development and implementation of improved quality reporting measures as required.
  • Review Annual Product Quality Reviews for all Ireland products
  • Creation and maintenance of all Product Quality Review schedules as required annually
  • Review all incoming batches of product for market release onto the Irish market
  • Liaising with the local primary wholesaler in order to ensure efficient release of batches for sale to the Irish market.
  • Maintenance of a record system for product certificates of analysis and batch release certificates for incoming batches
  • Providing training in all aspects of Quality Management Systems to both office and field based staff.
  • Responsible for maintaining documented training records.
  • The collection and coordination of quality related customer complaints, liaising with external sites in order to close out such complaints.
  • Effective management and control of deviations, change controls and CAPAs
  • Quality review and approval of Artwork components. Monitoring artwork used on stock being released onto the market to ensure compliance if required.
  • Interface between Regulatory Affairs, Marketing and Customer Service personnel
  • Leading Quality based projects working as part of a multidisciplinary team as required
  • Conduct self-inspections and external audits if required
  • Provide direct support during customer, supplier, regulatory and both internal and external audits as applicable
  • Review and approval of regulatory documentation if required
  • Support and assist RA department in preparing regulatory related SOP
  • Providing support to ensure variations have been implemented for the market.
  • Provide support for all medical information queries and adverse events received by the company in ensuring that they are passed on to the medical information team in the UK.
  • Support to the Responsible Person and Deputy Responsible Person to ensure compliance with EU Guidelines on Good Distribution Practice of Medicinal Products

Requirements

  • BSc in relevant area
  • Comprehensive experience of working in a similar Quality Assurance related role in the Pharmaceutical Industry
  • Experience and understanding in the area of Product Quality Reviews
  • Knowledge of EU quality related pharmaceutical regulations including both GDP and GMP legislation
  • Experience of conducting quality based investigations and root cause analysis
  • Experience of conducting self-inspections
  • Understanding and experience of deviations, change control, root cause analysis and CAPA's
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

Fastnet - The Talent Group
'Not Just Placers.........Partners'

The Life Science Specialists

This job originally appeared on RecruitIreland.com
Location Cork
Date Added 13 days ago
Apply Link
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