Senior Specialist, QA (Manufacturing Support)

About the role

Lonza is hiring a Senior Specialist, QA (Manufacturing Support) for its multi-product, cGxP contract manufacturing facility in Tuas, Singapore. This is a fully site-based shift role supporting day-to-day Quality Assurance activities in line with approved SOPs and policies, working closely with colleagues on the floor to manufacture medicines to the highest quality and safety standards.

Key responsibilities

• Coordinate lot disposition and product release, including shipping documentation.
• Review and approve SOPs, protocols, reports, batch records and other quality documents.
• Provide quality oversight of product status and the quality tag-out system.
• Review and approve deviation investigations using Root Cause Analysis, and oversee CAPA implementation and closure.
• Give real-time quality guidance on manufacturing floor activities in line with GMP, SOPs and policies.
• Support manufacturing changeovers and day-to-day QA activities in a GMP biopharmaceutical facility.
• Identify cGMP/GDP non-compliance and give corrective guidance.
• Analyze data, resolve quality issues and recommend process improvements.
• Take part in manufacturing walkdowns, regulatory and customer audits and follow-ups.
• Lead and coordinate quality projects and continuous improvement initiatives, and support cross-functional teams.

Required profile

• Degree from a recognized institution in a relevant discipline.
• 1-3 years of relevant experience, preferably in a biopharmaceutical or GMP-regulated environment.
• Hands-on experience collaborating with cross-functional teams on manufacturing activities.
• Meticulous, systematic and detail-oriented, with a focus on safety, quality, compliance and timelines.

Required skills

• Quality management systems
• GMP requirements

What we offer

• Competitive compensation programs recognizing high performance.
• Comprehensive medical insurance with family coverage at partially subsidized premiums.
• Company transport from designated MRT stations to the Tuas site.
• Cross-functional projects and global exposure for professional growth.