GMP/GxP QA Liaison
QRC Group, LLC•Caguas, PR
2d
About The Position
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.
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
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.
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