Vacancy Description
Key Responsibilities:
* Coordinate document lifecycle activities including creation, review, approval, training, revision, archival, and retirement.
* Support quality systems such as Document Management, Change Control, CAPA, Deviations, Training Management, Audit Management, and Supplier Quality.
* Review document change requests and assess impact on existing quality processes.
* Collaborate with Quality Assurance, Regulatory Affairs, Manufacturing, and business stakeholders to ensure timely document updates and approvals.
* Maintain compliance with GMP, GxP, FDA, EU, and internal quality standards.
* Support internal audits, external audits, and regulatory inspections by providing required documentation and evidence.
* Monitor quality metrics, generate reports, and identify opportunities for continuous improvement.
* ...
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