QA Specialist

1 week ago

Singapore GLOBAL LIFE SCIENCES SOLUTIONS SINGAPORE PTE. LTD. Full time
Roles & Responsibilities

Be part of something altogether life-changing

Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.

At Cytiva you will be able to continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients. With associates across 40+ countries, Cytiva is a place where every day is a learning opportunity – so you can grow your career and expand your skills in the long term.

Forming part of the Biotechnology segment at Danaher, we bring together dedicated technical expertise and talent to develop the next generation of life-changing therapeutics.

The QA Specialist for Cytiva is responsible to support QA operations in the manufacturing site, such as Change Control, Internal Quality Audit, Deviation and CAPA management, Documentation management, Training management etc.

This position is part of the Quality Assurance Department located at 25, Tuas South Street 1 Singapore and will be working on-site. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery.

In this role, you will have the opportunity to:

  • Performing batch record review and release, ensuring that products are released in a timely and compliant manner
  • Ensuring training program is executed according to training plan. Track and ensure that training is completed in a timely manner
  • Managing cGMP documents, ensuring that the procedures and forms are reviewed and revised according to schedule, including documentation archival and retention.
  • Performing routine audit trail review of critical data, upholding data integrity (ALOCA) principles
  • Printing and checking product labels, ensuring that they meet the required specifications
  • Conducting internal quality audits as a co-auditor
  • Providing support in both customer and quality system audits, interacting with both external certification bodies and customers in a professional and appropriate manner
  • Participating in quality investigations and continuous improvement projects
  • Supporting other quality activities such as validation, change control, CAPA where required

It would be a plus if you also possess previous experience in:

  • University degree in the Biological/Microbiological/Chemical Sciences or equivalent work experience
  • Extremely detail and accuracy-oriented with good written and verbal communication skills
  • Computer literate (Word, Excel, Oracle database, Electronic Documentation System) to create spreadsheets, e-mail, memos, graphic, etc. and technical writing skills (create and edit complex procedures)
  • Interact with internal and external customers, answering questions in a timely and professional manner
  • Problem solving ability (sound reasoning), choose appropriate course(s)of action when given a set of circumstances and exhibit familiarity with specific assigned tasks

It would be a plus if you also possess previous experience in:

  • Knowledge and experience of a GxP environment or other regulated industry
Tell employers what skills you have

GxP
Training Management
Cell
CAPA
Labels
Technical Writing
Quality Assurance
Quality System
Problem Solving
Audits
Change Control
Manufacturing
Writing Skills
Audit

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