Job Description

Key Responsibilities:

  • Administer and maintain controlled documents including SOPs, work instructions, policies, forms, and quality records.
    * 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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