Automation Engineer Team Lead

6 days ago


Dublin, Dublin City, Ireland Hamlyn Williams Full time

**Job Summary:**

We are seeking a highly experienced Quality Control professional to lead our team in ensuring compliance and timely resolution of product complaints.

  • The successful candidate will oversee all aspects of product complaints investigation, collaborate with cross-functional teams, and ensure EU/FDA cGMP requirements for complaint handling and reporting are met.
  • They will also support deviation management, CAPAs, audits, and risk management, as well as represent the company during internal and regulatory inspections.

**Key Responsibilities:**

  • Lead product complaints investigations to ensure compliance and timely resolution.
  • Collaborate with QA, Regulatory, Safety/Pharmacovigilance, Manufacturing, and CMOs.
  • Ensure compliance with EU/FDA cGMP requirements for complaint handling and reporting.
  • Support deviation management, CAPAs, audits, and risk management.
  • Represent the company during internal and regulatory inspections.

**Requirements:**

  • 5-9 years of experience in Quality Assurance, GMP, or related fields within pharmaceuticals, biotechnology, or medical devices.
  • Strong knowledge of GMP, regulatory requirements, and combination product complaint handling.
  • Excellent problem-solving, investigation, and documentation skills.
  • Ability to work independently and collaborate across departments.


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