Senior Specialist 1, Compliance (Quality)

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 to 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.

Did you know that we are the 1st biologics contract manufacturer in Singapore? We offer you exposure to upcoming biotech and established pharmaceutical companies and to the manufacturing technology needed to produce mammalian treatments and cell therapies of tomorrow. Our global manufacturing network is recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms and extensive experience – we, in Singapore are proud to be part of this global network.

The Senior QA Specialist will support day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for a multi-product, cGxP contract manufacturing facility in Quality Compliance (External).

What you’ll get

• An agile career and dynamic working culture.

• An inclusive and ethical workplace.

• Compensation programs that recognize high performance.

• Daily company bus from the MRT location near your home to and from the Tuas site.

• Fully paid medical insurance, and option to enrol family members at partially subsidized premiums.

The full list of our global benefits can be also found on https://www.lonza.com/careers/benefits.

What you’ll do

• Monitor day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for a multi-product, cGxP contract manufacturing facility

• Member of cross functional site team(s) on projects / issues  and  Coordinate between departments for multiple parallel activities

• Superior ability to troubleshoot

• Lead in complex deviation investigations, change controls, CAPA proposals

• A competent Reviewer and Approver of SOPs or records. 

• Understanding of advanced topics pertaining to cGMP. 

• Participate in Customer / Agency Audits and Inspections as required. 

• Identify process pathways and work to develop improvements in strategy. 

• Understands and articulates company business strategy. Maintains a broad view of the business, recognize changes and trends in the appropriate area in which the individual operates. 

• Uphold data integrity principle in accordance to Lonza policies. Proactively evaluate. identify and improve data integrity process.  

• Perform material release and qualification, joint inspection to identify material defect and review vendor’s investigation report as required. 

• Coordinates to deliver Supplier Quality Agreements in a timely manner 

• Owns documents of the assigned Quality Process when applicable 

• Develop skills to be Qualified Trainer in area of expertise 

• Subject Matter Expert in one or more area of expertise 

• Any other tasks as and when assigned by supervisor. 

What We’re Looking for

• Familiar with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA, and ICHQ7)

• Good knowledge and experience of the practical and theoretical requirement of quality management system in GMP facility

• Good interpersonal skills

• Effective Communicator (oral and written)

• Exhibit good quality decision making traits

• Meticulous, Systematic and Analytical Mind

• Team player who can operate independently, with strong focus on safety, quality and timelines

• Engineering/Science Degree or higher from recognized institution with 5 to 10 years’ experience in Quality unit in the Biopharmaceutical industry

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.