Quality Document Control

1 week ago

Singapur, Singapore Consortium for Clinical Research and Innovation, Singapore Full time

(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 Ensure superseded or obsolete documents are promptly removed from use.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. #J-18808-Ljbffr

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