Specialist 3, QA - #1209329

Today, Lonza is a global leader in life sciences operating across three 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.

This role is responsible to support day-to-day Quality Assurance activities in accordance with the approved SOP’s and policies.

Job Description:

• Support day-to-day Quality Assurance activities in accordance with approved SOPs /Policies for a large scale, multi-product, GMP biotech contract manufacturing facility.

• Able to plan for future activities and coordinate with other departments to complete this.

• Develops skills to be Qualified Trainer in area of expertise.

• In depth awareness of entire process; identifying operational factors which influence the process.

• Participates in Regulatory and Customer Audits.

• Able to participate actively or lead in deviation investigations, change controls, CAPA plans and closure of discrepancy reports.

• Makes real-time decisions on process events on the floor based on knowledge of defined SOPs & policies.

• Develops good working relationships with internal & external customers.

• A competent Reviewer and Approver of SOPs, protocols, reports or records.

• Leads a small team and provides supervision to QA Coordinators, interns or QA Specialists I and II.

• Any other tasks as and when assigned by supervisor.

Experience

• Diploma with 5 – 7 years’ experience in a similar type of industry or a similar job role

• Degree from recognized institution with 3 to 5 years’ experience in a similar type of industry or a similar job role.

• Well versed in cGMP regulations.

• Good problem solving and analytical skills.

• Good communication skills.

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.