Complete Trackwise 8 validation and risk assessments. Author validation protocols, reports and risk assessments. Critical thinking and problem solving.

As part of a team composed of engineers and consultants and accompanied by the departments concerned, your mission is to define and implement part of the…

Authoring validation protocols and final reports, executing validation studies, analysis of validation data. Authoring project validation master plans; SOP and…

Ensure all departments understand and comply with requirements defined in validation programmes, provide training as necessary.

Assists with the installation, debug and validation of process equipment; Assists with the installation, debug and validation of process equipment.

Work with Quality department to ensure validations are in line with customer validation standards. Prepare associated documentation for equipment and systems…

Support the client with Lab systems validation requirements. The successful candidate will focus on using lab informatics derived from LIMS to inform decision…

Liaise with multiple departments to ensure timely completion of validation activities. The site provides testing and technical services to the medical device…

Generating and executing validation documentation. Providing continuous improvement for existing validation procedures.

 Organize an efficient method to ensure all requirements of assigned validation deliverables are completed and that validation efforts are executed in a timely…

The purpose of the position is to provide Quality Engineering and Process Validation services for Continence products in the Ballina Continence Care Plant and…

+5 years’ experience in a cGMP regulated manufacturing environment, with knowledge of equipment and utility validation, and laboratory systems / validation.

Managing & coordinating validation documentation (risk assessments, traceability matrices, validation reports). Strong EUMDR experience highly preferred.

Generate and execute cleaning validation protocols as required. Technical and operational knowledge of Cleaning validation/verification, quality systems and…

Determine validation strategy and outcome of validation activities. Decision to approve or reject validation documentation. Job Type:Fixed Term Contract.

Development of the site validation strategy, validation plans, protocols and reports for all equipment and processes; incl.

A minimum of 2 years process validation experience. Software validation experience is desirable particularly in a 21 CFR Part 11 environment.

Proficient with 21 CFR Part 11, ICH guidelines, and FDA regulations on computer system validation. Coordinating multiple validation and qualification activities…

Develops and writes commissioning, qualification and validation documents. Present validation approach and study results to peers and managers.

Responsible for the creation of validation packages and review of all validation protocols and packages. Provide direction, documentation, execution and review…