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GMP/GxP QA Liaison
The QA Liaison ensures the project’s deliverables meet all GMP/GxP, data integrity, and document control requirements. This role acts as a bridge between the project team and Quality Assurance team.
Key Responsibilities
Ensure redesigned documents comply with regulatory frameworks including GMP/GxP, ALCOA+, and internal SOPs.
Validate controlled document release, versioning, approval workflows, and traceability.
Participate in risk assessments, ensuring proposed changes meet quality expectations.
Provide SMEs for data integrity, document retention, and regulated records processes.
Oversee compliance during on-site observations and stakeholder engagements.
Requisitos: Requirements: Requirements Extensive experience with GMP/GxP documentation processes and data integrity. Familiarity with manufacturing documentation types (batch records, SOPs, logbooks). Strong understanding of QA review processes and change management controls. Ability to work cross-functionally with operations, QA, and documentation teams. Willing to travel US-East Requiere Mucha Experiencia Requires Expert
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QRC GROUP LLC
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