Lead Specialist, QA (CGT)

Responsibilities

• Oversee daily Quality Assurance activities in a multi-product cGxP manufacturing environment, ensuring compliance with cGMP, SOPs, and company quality standards.
• Review and approve batch records, logbooks, SOPs, protocols, reports, deviations, CAPAs, change controls, and other quality documentation.
• Support batch disposition, product release, lot genealogy compilation, shipping documentation, and quality tag-out processes.
• Lead and support deviation investigations, root cause analysis, CAPA implementation, and continuous improvement initiatives.
• Provide QA oversight on manufacturing operations, document changes, process changes, and shop floor activities.
• Participate in regulatory inspections, customer audits, and cross-functional projects, ensuring audit readiness and compliance.
• Drive data integrity initiatives and promote adherence to GDocP and quality requirements.
• Train and mentor team members, provide quality guidance to operations, and act as a supervisor when required.
• Collaborate with stakeholders to resolve quality issues, support business objectives, and implement process improvements.
• Lead complex investigations and quality projects while making sound risk-based quality decisions.
• Any other tasks as and when assigned by supervisor
• Willingness to work in a rotating 12-hour shift pattern.

Requirements

• Bachelor's degree with relevant experience in Quality Assurance within the biopharmaceutical sector.
• Proven experience in QA operations in a GMP-regulated biopharma environment.
• Practical experience collaborating with cross-functional manufacturing teams.
• Solid understanding of quality management systems and GMP compliance requirements.
• Familiarity with regulatory guidelines such as FDA, EMA, and ICH.
• Strong analytical, problem-solving, communication, and organizational abilities.
• Detail-oriented, structured, and a strong team player with a focus on safety, quality, and meeting timelines
• About Lonza
• Ready to shape the future of life sciences?

Additional Information

The Lead QA Specialist will support day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for a multi-product, cGxP contract manufacturing facility Find out more about what a life at Lonza in Singapore could look like for you by watching this short video. This is a fully site ‑ based role. Working together in person supports close, real ‑time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards. This is a rotating 12-hour shift role. 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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