Specialist QA CGT

2 weeks ago

West Region, Singapore Randstad – Lonza Full time $104,000 - $130,878 per year

As a Specialist, QA (CGT) at Lonza, you will support day-to-day Quality Assurance activities in accordance with approved SOPs and policies for a multi-product, cGxP contract manufacturing facility. You will play a key role in providing QA oversight for operations, compliance, and documentation, ensuring that products meet the highest quality standards and are released on time.


What you'll get
  • An agile career and dynamic working culture.
  • An inclusive and ethical workplace.
  • Compensation programs that recognize high performance.
  • Daily company bus from the MRT location near your home to and from the Tuas site.
  • Fully paid medical insurance, with the option to enroll family members at partially subsidized premiums.
  • Access to Lonza's full global benefits portfolio:

What you'll do
  • Review executed batch records, logbooks, and documentation to ensure compliance with cGMP and GDocP.
  • Compile lot genealogy and disposition packages to drive timely product release.
  • Provide QA oversight for product status, shipping documents, and quality tag-out systems.
  • Support and approve deviation investigations, CAPA implementation, and timely closure of quality events.
  • Oversee and approve changes to operational documents (e.g., MBRs, SOPs, Forms, Logbooks).
  • Participate in QA shopfloor activities, changeovers, walkdowns, and audits (regulatory/customer).
  • Lead and coordinate site projects, investigations, and change controls as needed.

What we're looking for
  • Degree or Diploma in Science or Engineering.
  • Experience in Quality Assurance within a cGMP manufacturing environment, ideally in Cell and Gene Therapy (CGT) or biopharmaceuticals.
  • Strong knowledge of cGMP, GDocP, and applicable regulatory requirements.
  • Hands-on experience with batch record review, deviation management, and CAPA implementation.
  • Proven ability to lead investigations, change controls, and cross-functional projects.
  • Effective communication and stakeholder management skills

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