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Laboratory Documentation and Data Integrity Specialist

2 weeks ago

Sligo, Sligo, Ireland TN Ireland Full time

TN Ireland is seeking a skilled Senior Laboratory Quality Assurance Specialist to join our team.

About the Role:

  • This is an excellent opportunity to contribute to a world-class manufacturing operation with a strong culture of continuous improvement and innovation.
  • The successful candidate will maintain and align laboratory documentation and computerized systems data integrity requirements.
  • Strong knowledge of regulations and business processes required to maintain laboratory data integrity is essential.

Key Responsibilities:

  • Carry out environmental and product microbiological tests as required.
  • Define and update procedures for plant relative to microbiological and environmental testing.
  • Complete validation of equipment and test methods for microbiological tests.
  • Test method transfer of microbiological methods.
  • Develop microbiological laboratory procedures.
  • Maintain up-to-date and detailed records of all tests performed.
  • Adhere to and support all EHS & E standards, procedures, and policies.

Requirements:

  • A good knowledge of aseptic processes' manipulation together with experience within a GLP/GMP environment and knowledge of current EU/FDA/ICH/HPRA guidelines.