Senior Specialist, QA (Technical Support - Validation)

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

Benefits offered by this job

Comprehensive medical insurance

Family coverage option

Company transport from MRT locations

Global exposure to Lonza’s life-scient

Employee benefits portal

Job summary

Lonza Singapore Tuas site is seeking a Senior QA Specialist to support QA technical activities and ensure cGMP conformity in validation efforts. This fully site-based role emphasizes close in-person collaboration for precise manufacturing quality.

You will review and approve validation master plans, protocols, and reports, provide QA oversight during execution, and drive CAPAs and continued process verification to sustain product quality and regulatory compliance.

Qualifications

• Experience in Validation / Quality unit in biopharma or related industry.
• Strong knowledge of cGMP requirements and regulatory expectations.
• Ability to review validation Master Plans, protocols, and reports.

Responsibilities

• Review and approve the Validation Master Plan and processes to meet cGMP and regulatory standards.
• Provide QA oversight during validation to ensure adherence to SOPs and protocols.
• Review discrepancies/deviations, conduct root-cause analysis, and manage CAPAs.
• Review validation reports ensuring acceptance criteria are met and data justified.
• Review CPV protocols and reports to assure ongoing process performance and product quality.

Skills

QA Oversight

Validation

cGMP

CAPA

Education

Degree in Biological Science / Engineering

Job description

Singapore, Tuas Singapore

As a Senior QA Specialist, you will support the QA technical support team .

This is a fully site‑based role at Singapore Tuas. Working together in person supports close, real‑time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards.

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

• Review and approve the Validation Master Plan (VMP), process validation protocols (including Process Performance Qualification and supporting studies), ensuring alignment with cGMP requirements, applicable regulatory standards, Lonza policies and procedures, and customer expectations.
• Provide QA oversight during validation execution to ensure strict adherence to approved protocols and standard operating procedures (SOPs).
• Review and approve discrepancies and deviations arising during validation activities; ensure thorough investigation, robust root cause analysis, and appropriate assessment of impact on validation status. Oversee approval and timely closure of associated Corrective and Preventive Actions (CAPAs).
• Review and approve validation reports, confirming that all acceptance criteria are met, deviations are adequately resolved or justified, and conclusions are data-driven and fully compliant with regulatory expectations.
• Review and approve Continued Process Verification (CPV) protocols and reports to ensure ongoing assurance of process performance and product quality.

What We’re Looking For

• Degree in Biological Science / Engineering and experience in Validation / Quality unit in the Biopharmaceutical industry .
• 5-8 years of experience in a similar type of industr y or a similar job role.
• Able to operate independently with minimum supervision.
• Fair knowledge and experience of the practical and theoretical requirement of quality management system in a GMP facility
• Team player, with strong focus on safety, quality 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: R76460