QA Specialist

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 for supporting 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: Perform batch record review and release, ensuring that products are released in a timely and compliant manner. Ensure training program is executed according to training plan and track completion in a timely manner. Manage cGMP documents, ensuring that procedures and forms are reviewed and revised according to schedule, including documentation archival and retention. Perform routine audit trail review of critical data, upholding data integrity (ALOCA) principles. Print and check product labels, ensuring that they meet the required specifications. Conduct internal quality audits as a co-auditor. Provide support in both customer and quality system audits, interacting with external certification bodies and customers in a professional manner. Participate in quality investigations and continuous improvement projects. Support other quality activities such as validation, change control, and CAPA as required. It would be a plus if you also possess previous experience in: University degree in Biological/Microbiological/Chemical Sciences or equivalent work experience. Detail-oriented with good written and verbal communication skills. Computer literate (Word, Excel, Oracle database, Electronic Documentation System) with technical writing skills. Ability to interact with internal and external customers, answering questions in a timely and professional manner. Problem-solving ability with sound reasoning skills. Knowledge and experience of a GxP environment or other regulated industry is a plus. #J-18808-Ljbffr