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Quality Officer 65k

Job description

My client a world leader in healthcare urgently require a Quality Officer

He/she will manage and co-ordinate Quality Assurance activities and resources associated with product release.

In the role one will be responsible for compliance in-house requirements and cGMPs.

Whay you'll need :

  • Responsible for the continuous review of the CAPA & Internal & Compliance programs.
  • Can implement process improvements to ensure predictable processes across all lines.
  • Responsible for facility compliance with regulatory commitments, in-house requirements & GMP.
  • Introduction of quality systems in line with industry practices and GMP requirements.
  • Preparation of procedures and policies for area of responsibility
  • Responsibility for maintenance and development of GMP awareness facility-wide, including:
  • Preparation and execution of training programmes, assessment of GMP training requirements etc. 
  • Investigation for QA review of all GMP critical documents.
  • In-house auditing.
  • Line clearance procedures.
  • Exception and deviation management e.g. deviations, Alarms, OOS, etc.
  • Validation: Define process, product and test method validation requirements,
  • Compilation of required Regulatory documentation.
  • Educational Requirements:
  • Minimum qualification: BSC/BEng degree.
  • Familiar with Quality Systems: ISO 17025, ISO 14001, OHSAS 18001 
  • Minimum of 3 years experience in a QA role within a regulated environment.
  • For more information please call Colin by E-Mail codonnell@sigmar.ie

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