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Complaints Investigation Lead

3 weeks ago

Dublin, Dublin City, Ireland Quanta Consultancy Services Ltd Full time

We are looking for a highly skilled Complaints Investigation Lead to join our team at Quanta Consultancy Services Ltd. This is an exciting opportunity for a professional with extensive experience in quality assurance or a GMP related field to lead our Quality Control Team.

About the Role

The Complaints Investigation Lead will be responsible for ensuring that all product complaints are thoroughly investigated to identify root causes and implement corrective actions. This includes coordinating all aspects of investigation through to closure and/or providing oversight for complaint handling process.

You will apply departmental procedures to assess product complaints' impact on patient safety and product quality compliance. Additionally, you will assess product complaints and determine if escalation is required due to potential regulatory notification requirements.

You will interface and collaborate with various departments including the OpUs, External Supply, Quality Assurance, Regulatory, Development, Safety/Pharmacovigilance, etc. and the regional organisation. You will also interface with external stakeholders such as CMO, Call Centres and vendors/contractors on product complaint issues.

Responsibilities

Your key responsibilities will include:

  • Receiving, initiating, investigating and concluding product complaint investigations using the current product complaints management mailbox and software.
  • Coordinating all aspects of investigation through to closure and/or providing oversight for complaint handling process.
  • Applying departmental procedures to assess product complaints' impact on patient safety and product quality compliance.
  • Assessing product complaints and determining if escalation is required due to potential regulatory notification requirements.
  • Interface and collaboration with various departments and external stakeholders.