Analyst (BioChemistry), QC

2 weeks ago

Singapur, Singapore Lonza Full time

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 ? 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 QC Analyst will be responsible for Biochemistry Area in the QC Lab to support Lot Release activities
 

Responsibilities

Prioritize and perform the various testing/analysis in timely manner, in order to support the business requirements.

Analysis of final product, in-process, stability samples according to Standard Operating Procedures and Test Methods.

Documentation and review of results in accordance with current Good Manufacturing Practices (cGMP).

Understanding and execution of methods which may include ELISA, PCR, CE, SDS-PAGE, IEF, icIEF, potency methods, and other physiochemical methods.

General lab support including housekeeping, equipment maintenance, inventory of supplies, lab supplies ordering, management of glass wares, autoclaving etc.

Prepare, maintain standards and reagents as required by GMP documents.

Responsible to follow data integrity requirements.

Actively contributes to operational efficiency/continuous improvement initiatives.

Problem solving of analytical methods as well as troubleshooting of equipment.

Involved in equipment qualification, maintenance and troubleshooting.

Support / Perform OOS, deviation investigations. Draft investigations reports.

Be a trainer for test method.

Involvement in method transfers and validation.

Author Change Controls, Test Methods, SOPs.

Lead Out-Of- Specifications (OOS) and deviation investigations.

Education / Experience

Diploma / Degree or higher from recognized institution with at least 3 years’ experience in Quality unit in the Biopharmaceutical industry

Relevant work experience preferably Lab experience in a biotech or medically related field

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

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

Is willing to take on new challenges

Good interpersonal skills

Effective Communicator (oral and written)

Plans, prioritizes and organizes work to deliver on time

Exhibit good quality decision making traits

Meticulous and Systematic and Analytical Mind

Team player who can operate independently, 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.

Reference: R61068

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