Test Method Validation Engineer

Harmonics Recruitment

Sligo, Mayo

General Responsibilities: Responsible for the development of and adherence to quality systems that involve test method validations. Overall responsibility for Test Incident Handling and Managing Issues Log. Overall responsibility for control / resolution and correct documentation of Protocol Amendments / Discrepancies (deviations. Ensure that the required sequences of events is achieved throughout the validation effort. Ensure timely approval of validation documents (e.g. Protocols and Protocol Reports. Application of the appropriate Risk Assessment tools to allow determination of the appropriate Risk level V’s patient safety. Application of the appropriate problem solving tools to resolve possible project roadblocks. Control the Validation Package and ensure that all documents contained in the Validation Package meet the requirements of the Corporate or Regulatory Requirements. Overall responsibility to ensure that the validation effort does not negatively impact business deadlines. Have excellent knowledge of and ability to provide Interpretation and Guidance on Regulations, Corporate, Divisional and Site Local Procedures as they relate to Test Method Validation activities. Education & Requirements: Minimum of 3 to 4 years direct experience in a relevant validation role in either Medical device or Pharmaceutical Industry. High level of PC skills required. This job originally appeared on RecruitIreland.com.

2646 days ago