Validation and Compliance Specialist

7 days ago


City of Greater Geelong, Australia Alimentiv Inc. Full time

The Validation and Compliance Specialist will play a key role in ensuring the quality and integrity of our technology solutions. As a member of our quality management team, you will be responsible for executing assigned actions related to the corporate Quality Plan, providing guidance to eQMS modules users, reviewing and approving technology change requests and CAPAs submitted by internal stakeholders, and supporting team members responsible for authorizing or rejecting change requests from a technology quality and validation perspective.

Your primary focus will be on ensuring that technology solution projects meet established standards and quality expectations, including validation, access control, audit trail reviews, and system reviews. You will also be responsible for monitoring, identifying, and implementing continuous process improvement across technology platforms impacting clinical research.

To succeed in this role, you will need excellent analytical, critical thinking, problem-solving, and attention to detail skills, as well as strong interpersonal, verbal, and written communication skills. Knowledge of ICH GCP and global regulations governing technology platforms in clinical research is required.



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