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GxP Compliance Specialist

1 week ago

Singapore This is an IT support group Full time
About Our Company

Lonza is a global leader in life sciences, operating across three continents.

We believe that our greatest scientific solution is talented people working together, devising ideas that help businesses to help people.


Job Responsibilities

As a QA Specialist, you will provide oversight into manufacturing in a large-scale, multi-product, GMP biotech contract manufacturing facility.

Your key responsibilities will include:

  • 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.

Requirements

To succeed 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.