Senior Specialist, QA (CGT)

Responsibilities

• Identify cGxP/cGDP non-compliance, provide guidance, and support basic compliance queries across departments.
• Review batch records and logbooks, raise deviations, compile lot genealogy, and prepare lot disposition packages to ensure timely product release.
• Oversee product status, shipping documentation, material release, joint inspections, and quality tag-out processes.
• Participate in deviation investigations using RCA tools and ensure timely CAPA implementation and closure.
• Provide QA oversight for document changes, changeovers, and Quality Change Requests.
• Conduct shopfloor walkdowns, escalate process events per SOPs, and support regulatory and customer audits.
• Lead or support QA projects and build strong working relationships with internal and external stakeholders.
• Demonstrate effective problem-solving skills, data analysis, and strong interpersonal collaboration.
• Any other tasks as and when assigned by supervisor

Requirements

• Degree in science or related field
• Relevant work experience in Pharmaceutical Manufacturing industry or Validation / Quality unit in the Biopharmaceutical industry
• Familiar with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA, and ICHQ7)
• Knowledge and experience of the practical and theoretical requirement of quality management system in GMP facility
• Team player who can operate independently, with strong focus on safety, quality and timelines
• About Lonza
• Ready to shape the future of life sciences?

Additional Information

The QA Specialist will support day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for a multi-product, cGxP contract manufacturing facility Join our best-in-class high performance Integrated Biologics team at our Tuas site in Singapore to gain unparalleled exposure to cutting-edge biotechnology and innovation. Learn new skills and capabilities. Grow your career with us in manufacturing therapeutic proteins under cGMP conditions. Find out more about what a life at Lonza in Singapore could look like for you by watching this short video. What you'll get An agile career and dynamic working culture in a global life sciences leader. An inclusive and ethical workplace that values diversity and integrity. Competitive compensation programs that recognize high performance. Professional growth opportunities through cross-functional projects and global exposure. Comprehensive medical insurance, with the option to enroll family members at partially subsidized premiums. Company transport provided from designated MRT locations to and from the Tuas site. Access to Lonza's full suite of employee benefits: www.lonza.com/careers/benefits

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