Summary:

Responsible for managing controlled documents and supporting Quality Systems in compliance with GMP, GDP, FDA, and GxP regulations.

Key Responsibilities

Manage SOPs, Work Instructions, Forms, and Quality Documents.

Support Change Controls, Deviations, CAPAs, and Audit activities.

Maintain document control and revision history.

Review documentation for GMP/GDP compliance.

Support training records and document workflows.

Assist with validation documentation (IQ/OQ/PQ).

Required Skills

GMP, GDP, GxP Compliance

Document Control

SOP Authoring & Review

CAPA, Deviations, Change Control

Data Integrity (ALCOA+)

Audit & Inspection Support

Technical Writing

Microsoft Office Suite

Preferred Skills

Veeva Vault, MasterControl, TrackWise, ETQ

Validation Documentation (IQ/OQ/PQ)

FDA 21 CFR Part 11, 210, 211

Quality Management Systems (QMS)

Pharma, Biotech, or CDMO experience