Senior Specialist, QA (Mfg Support)

Lonza; Singapore; On-site; Confidential; Full time

Benefits offered by this job

Medical insurance (family option)

Transport to Tuas site

Job summary

Lonza Singapore is seeking a QA Operations professional to support manufacturing in a GMP biopharmaceutical facility at Tuas. You will coordinate batch release, review documents, and ensure compliance across quality systems.

With 1–3 years of relevant experience, you will collaborate with cross-functional teams to uphold risk management and continuous improvement, while adhering to regulatory requirements and safety standards at Lonza.

Qualifications

• Bachelor's degree in a life sciences or related field.
• 1-3 years' QA or GMP-regulated experience in biopharma.
• Experience reviewing SOPs, batch records, and deviations.
• Familiarity with quality systems and regulatory requirements.

Responsibilities

• Coordinate lot disposition and product release activities, including shipping documents.
• 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 deviation investigations and apply RCA for timely closure.
• Oversee CAPA implementation and closure.
• Provide QA guidance on manufacturing floor activities per GMP and SOPs.
• Support manufacturing changeovers and day-to-day QA in GMP facility.
• Identify cGMP/GDP non-compliance and provide corrective guidance.
• Analyze data to resolve quality issues and suggest process improvements.
• Participate in audits and follow-up activities.
• Lead Quality projects and continuous improvement initiatives.
• Provide compliance guidance to cross-functional teams.
• Build relationships with stakeholders.
• Perform other duties as assigned.

Skills

QA Operations

GMP Compliance

Cross-functional collaboration

Root Cause Analysis

Quality Management Systems

Education

Bachelor's degree in Life Sciences or related field

Tools

QMS (Quality Management System)

Job description

Singapore, Tuas Singapore

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

What You'll Do

• Coordinate lot disposition and product release activities, including shipping documentation.
• Review and approve SOPs, protocols, reports, batch records, and other quality-related documents
• Provide Quality oversight of product status and the quality tag-out system.
• Review and approve deviation investigations, applying Root Cause Analysis to support timely closure.
• Oversee CAPA implementation and ensure timely and effective closure.
• Provide real-time Quality guidance on manufacturing floor activities in accordance with GMP, SOPs, and policies.
• Support manufacturing changeovers and day-to-day QA activities within a GMP biopharmaceutical facility.
• Identify cGMP/GDP non-compliance and provide appropriate corrective guidance.
• Analyze data, resolve quality issues, and recommend process improvements.
• Participate in manufacturing walkdowns, Regulatory and Customer Audits, and related follow-up activities.
• Lead and coordinate Quality projects and continuous improvement initiatives.
• Provide compliance guidance and Quality support to cross-functional teams.
• Build strong relationships with internal and external stakeholders.
• Perform other duties as assigned by the supervisor.

What We're Looking For

• Degree from a recognized institution in a relevant discipline.
• 1-3 years of relevant experience in a similar role, preferably within a biopharmaceutical or GMP-regulated environment.
• Relevant QA Operations experience in a biopharmaceutical manufacturing environment.
• Hands-on experience working and collaborating with cross-functional teams on manufacturing activities.
• Good understanding of Quality Management Systems and GMP requirements.
• Meticulous, systematic, and detail-oriented.
• Strong team player with a focus on safety, quality, compliance, and timelines

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone's ideas, big or small, have the potential to improve millions of lives, and that's the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you're ready to help turn our customers' breakthrough ideas into viable therapies, we look forward to welcoming you on board.

Reference: R80071