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Quality Management System Leader

1 week ago

Singapore This is an IT support group Full time
Role Overview

This QA Specialist role provides oversight into manufacturing in a large-scale, multi-product, GMP biotech contract manufacturing facility.

You will be responsible for:

  • Supporting day-to-day QA activities in compliance with SOPs/policies in a multi-product, GxP contract manufacturing facility.
  • Ensuring process awareness, identifying operational factors affecting the process.
  • Reviewing and approving SOPs, protocols, reports, and records.
  • Troubleshooting issues, weighing all information to determine optimal solutions.
  • Leading small projects and managing deliverables effectively.
  • Building strong working relationships with internal and external customers.
  • Planning and coordinating future activities with other departments.
  • Developing into a qualified trainer in the area of expertise.
  • Reviewing batch records, raising deviations, and compiling lot genealogy.
  • Escalating process events based on SOPs/policies.
  • Supporting changeover activities and providing oversight for document changes.
  • Detecting non-compliance with cGMP/GDP, providing corrective guidance.
  • Participating in walkdowns, audits, and providing feedback for improvement.
  • Leading or participating in deviation investigations, change controls, and CAPA plans.

Qualifications

To be successful in this role, you should have:

  • A degree from a recognized institution with 3 to 5 years' experience in a similar type of industry or a similar job role.
  • A diploma with 5 – 7 years' experience in a similar type of industry or a similar job role.
  • Familiarity with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA, and ICHQ7).
  • Fair knowledge and experience of the practical and theoretical requirement of quality management system in a GMP facility.
  • Meticulous and systematic, team player, with strong focus on safety, quality, and timelines.
  • Able to operate independently with minimum supervision.