- To perform QC test as required.
- 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 manage multiple priorities and lead projects.
- Source of expertise for rest of staff.
- Customer and regulatory agency interaction as required.
- Problem solving of analytical/ microbiological methods as well as troubleshooting of equipment as applicable.
- Manage/perform equipment qualification and validation maintenance review.
- Lead/ execute method transfers and validation/ qualification.
- In addition the technical contributions above, Section Leads and Senior Section Leads are expected to manage associates.
- Any other duties as assigned by your Manager.
- Degree/Diploma in a relevant Chemistry, Science field or Equivalent.
- Relevant work experience preferably with Lab experience in a biotech or medically related field.
- Relevant experience and accomplishment to dictate final position for which the candidate may qualify.
- Well versed in cGMP regulations.
- Knowledge of area specific responsibilities.
- Good problem solving and analytical skills.
- Good communication skills.
- A key team player.
- Able and willing to work on 12 hours shift.
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Section Lead, QC - Singapur, Singapore - Lonza
Description
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 Section lead will be responsible to supervise the QC shift team and perform and review testing to support manufacturing process. Primary methods used during daily testing activities are: UV Spectroscopy, UV SoloVPE, HPLC, TOC, pH, Conductivity, Osmolality. This role is also required to supervise the review of laboratory data (both internal and external) and the closeout of deviations.
Key responsibilities:
Key requirements:
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: R55662
