Specialist 2, QA (Validation and Technical Compliance)

Lonza Biologics Tuas Pte Ltd; Singapore; On-site; Confidential; Full time

Job summary

A leading biopharmaceutical company in Singapore seeks a dedicated Quality Assurance professional to provide oversight in laboratory services. The role requires a Bachelor's degree and significant experience in the Biopharmaceutical industry, with strong familiarity with regulatory requirements. Candidates must be meticulous, systematic, and a team player focused on safety and quality. The company offers competitive compensation and a dynamic working culture, with career growth opportunities in a global environment.

Benefits

Comprehensive medical insurance

Company transport from designated MRT locations

Professional growth opportunities

Qualifications

• Significant experience in Quality Assurance in the Biopharmaceutical industry.
• Familiarity with regulatory requirements (FDA, EMA, ICH).
• Meticulous and systematic approach to work.

Responsibilities

• Provides QA oversight to QC/DS laboratory services.
• Review and approve protocols and reports.
• Liaise with cross functions, communicating information and updates.

Skills

Quality Assurance

Regulatory requirements

Quality management systems

Root Cause Analysis

Team collaboration

Education

Bachelor's degree in a relevant field

Job description

Overview

Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

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

What you’ll do

• Provides QA oversight to QC/DS laboratory services
• Review and approval of protocols and reports.
• Provide QA oversight in deviation investigation, discrepancy reports and CAPA implementation.
• Participate actively, utilizing Root Cause Analysis tools to enable effective and timely closure of records.
• Provides Quality Change Request oversight for Lab service changes.
• Liaise with cross functions, communicating information and updates in timely manner
• Develops good working relationships with internal & external customers.
• Participate in cross-functional walk down and provide feedback
• Develop skills to be Qualified Trainer in area of expertise
• Develop skills to front auditors as SME/ supporting QA oversight

What we’re looking for

• Bachelor's degree with significant years’ experience in Quality Assurance in the Biopharmaceutical industry.
• Familiarity with Regulatory requirements and local Codes & Standards (eg. FDA, EMA and ICH Quality Guidelines)
• Fair knowledge and experience of the practical and theoretical requirement of quality management system in a GMP facility.
• Able to operate independently with minimum supervision for routine work within established policies and procedures and receives detailed instructions on new projects and assignments.
• Meticulous and Systematic.
• Team player, with strong focus on safety, quality and timelines.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.