Senior Specialist, Customer Project, Qc

3 days ago

Tuas, 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 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.

As a Senior Specialist QC, you will be responsible for the supervision of all testing techniques and scheduling of testing with coordinating with the other departments delivering samples to ensure timely delivery of results. This role is also required to supervise the review of laboratory data (both internal and external) and the closeout of deviations.

**Responsibilities**:

- Supervising the review of laboratory data (both internal and external) and the closeout of deviations
- Author and review Change Controls, Deviations/Investigation as well as Test Methods, Specifications and SOPs
- Perform report writing (Example: Deviations/Investigations/Trending)
- Maintains knowledge of new technologies
- Strong ability to prioritise multiple priorities and lead projects.
- Customer and regulatory agency interaction as required
- Problem solving of analytical/ microbiological methods as well as troubleshooting of equipment as applicable.
- Perform equipment qualification and validation maintenance review
- Lead/ complete method transfers and validation/ qualification.
- Collect and analyze data related to quality metrics e.g. using statistical tools to identify trends, patterns, and potential areas for improvement
- Participate in Risk Assessment
- SME in 1 or more areas as aligned with training plan and known as go to person for technical advice.
- Able to make decision on the area of expertise
- Coach and train junior team member
- Participate and support in audit
- Any other duties as assigned by your manager

**Job Experience**:

- Bachelors with relevant science field or equivalent.
- Minimum of 7 years of experience in GMP (Good Manufacturing Practice) Quality.
- Relevant work experience, preferably in a laboratory setting, within the biotech or medical field.
- Individual contributor, high level understanding of QC activities and lab function

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.

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