Document Controller

Role Overview

The QA Document Controller will be responsible for overseeing the daily handling, distribution, archiving, and upkeep of Good Manufacturing Practice (GMP) documentation at the client’s facility. The position ensures that all site Standard Operating Procedures (SOPs), batch records, technical protocols, and training files comply with strict EU/FDA GxP regulatory requirements.

Key Duties

• Manage the entire lifecycle of site-controlled documents—including SOPs, Work Instructions, Forms, Batch Execution Records, and Specifications—utilizing Electronic Document Management Systems (EDMS) for creation, review, approval, revision, and retirement processes.
• Oversee quality and compliance aspects to guarantee all document workflows adhere to the site’s Quality Management System (QMS), Annex 11 and CFR Part 11 Data Integrity standards, along with ALCOA+ principles.
• Maintain both physical and electronic archives, enforcing secure record retention schedules and facilitating expedited record retrieval for internal reviews, customer inquiries, and regulatory audits such as HPRA and FDA inspections.
• Support training administration by acting as the local administrator for Quality Management and Learning/Training platforms (e.g., electronic Learning Management Systems), monitoring document-driven training workflows before implementation dates.
• Drive continuous improvement by tracking document change controls, spotting process bottlenecks, and compiling monthly KPI reports focusing on review timelines and document aging metrics.

Candidate Requirements

• A diploma or bachelor’s degree in Science, Engineering, Business, or a closely related field.
• At least two years of experience in documentation control or quality assurance administration within a regulated pharmaceutical or medical device environment.
• Proficient in using EDMS software such as Veeva, TrackWise, Documentum, or MasterControl, alongside Learning Management Systems.
• Strong knowledge of current Good Manufacturing Practice (cGMP) principles, Good Documentation Practice (GDP), and data integrity protocols.
• Willingness and ability to perform full-time onsite work, five days per week.