Quality Assurance Professional

6 days ago

Singapore beBeeQuality Full time $90,000 - $120,000

We are looking for a Quality Assurance Specialist to join our team. The ideal candidate will have experience in quality assurance within a controlled environment, preferably in biopharmaceuticals or cell and gene therapy.

Job Description

The Quality Assurance Specialist will be responsible for ensuring that products meet the highest quality standards and are released on time. This includes reviewing batch records, logbooks, and documentation to ensure compliance with good manufacturing practices (GMP) and other regulatory requirements.

The successful candidate will also be responsible for compiling lot genealogy and disposition packages, providing QA oversight for product status, shipping documents, and quality tag-out systems, as well as supporting and approving deviation investigations and change controls.

In addition, the Quality Assurance Specialist will participate in QA shopfloor activities, changeovers, walkdowns, and audits, and lead and coordinate site projects, investigations, and change controls as needed.

Required Skills and Qualifications
  • Degree or Diploma in Science or Engineering
  • Experience in Quality Assurance within a controlled environment, preferably in biopharmaceuticals or cell and gene therapy
  • Strong knowledge of GMP, 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
Benefits

We offer an agile career and dynamic working culture, an inclusive and ethical workplace, compensation programs that recognize high performance, fully paid medical insurance, and access to our full global benefits portfolio.

What You'll Do
  1. Review executed batch records, logbooks, and documentation to ensure compliance with GMP and GDocP
  2. Compile lot genealogy and disposition packages to drive timely product release
  3. Provide QA oversight for product status, shipping documents, and quality tag-out systems
  4. Support and approve deviation investigations, CAPA implementation, and timely closure of quality events
  5. Oversee and approve changes to operational documents
  6. Participate in QA shopfloor activities, changeovers, walkdowns, and audits
  7. Lead and coordinate site projects, investigations, and change controls as needed

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