Quality Document Control & Training Specialist

Consortium for Clinical Research and Innovation, Singapore; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A leading healthcare research organization in Singapore is seeking a Senior Quality Document Control & Training Specialist. The role involves overseeing GMP document control processes and managing training records. The ideal candidate will have 3-5 years of experience in a pharmaceutical quality system and a background in science or engineering. This opportunity is pivotal for ensuring compliance and maintaining quality standards in clinical research documentation.

Qualifications

• Minimum of 3 to 5 years of relevant experience in Pharmaceutical Quality System.
• Knowledge of GMP/GDP/HSA/HPRA regulatory requirements.
• Strong understanding of quality management concepts.

Responsibilities

• Lead GMP document control for ACTRIS including creation and management.
• Administer the document control system and ensure compliance.
• Support the GMP training program and maintain training records.

Skills

GMP Document Control

Quality Management Concepts

Regulatory Compliance (GMP/GDP)

Education

Diploma or Degree in Science, Engineering and Life Sciences

Job description

(Senior) Quality Document Control & Training Specialist, ACTRIS

Overview

The Consortium for Clinical Research and Innovation, Singapore (CRIS) brings together seven national R&D, clinical translation and service programmes to advance clinical research and innovation for Singapore, and establish important capabilities for a future-ready healthcare system.

The Business Entities under CRIS include:

• Singapore Clinical Research Institute (SCRI)
• National Health Innovation Centre (NHIC)
• Advanced Cell Therapy and Research Institute, Singapore (ACTRIS)
• Precision Health Research, Singapore (PRECISE)
• Singapore Translational Cancer Consortium (STCC)
• Cardiovascular Disease National Collaborative Enterprise (CADENCE)
• SIngapore Medical FOundation AI model (SIMFONI)

Together, CRIS makes a positive difference to Singapore patients and researchers by ensuring that these clinical research platforms and programmes are at the cutting edge of capability development and innovation. If you are as passionate as we are in clinical trials and research, we want you!

ACTRIS

The Advanced Cell Therapy and Research Institute, Singapore (ACTRIS) was established to meet the increasing clinical demand of using cellular Therapeutics the national and regional Centre of Excellence for discovery, process development and manufacturing of cellular-based therapeutics across the broad encompassing both investigational and approval products for the local market. We also provide value-added services such as workforce training, regulatory delivery of cellular therapy to patients.

What you will be working on

Document Control & Documentation Administration

• Act as the GMP Document Control lead for ACTRIS.
• Administer the GMP document control system, including document creation, formatting, routing, approval, issuance, version control, archiving, and retrieval.
• Manage the full document lifecycle, including periodic review, revision control, and retirement of obsolete documents.
• Provide quality oversight for gap and/or quality risk assessments between assigned quality management process and applicable CTGTP / GMP / GDP regulations, guidance and industry standards.
• Ensure superseded or obsolete documents are promptly removed from use.
• Maintain secure and compliant storage of electronic and physical GMP documents in accordance with data integrity requirements.
• Support departments with document templates, formatting, and document control processes.
• Track document status and generate document control lists or metrics as required.
• Support Quality Managers in internal audits, supplier audits and external agency inspections preparation.
• Other responsibilities as assigned by Quality Managers.

Training Administration

• Support the administration of the GMP training program.
• Maintain accurate and up‑to‑date GMP training records.
• Track training assignments and completion status.
• Support onboarding and periodic GMP training activities.

What we are looking for

Education, Training

• Diploma or Degree in Science, Engineering and Life Sciences

Experience

• A minimum of 3 to 5 Years of relevant working experience in Pharmaceutical Quality System in GMP / GDP / ATMP relevant industry.
• Relevant knowledge in GMP / GDP / HSA / HPRA regulatory requirements
• Proficient in Quality Management Concepts.