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 QA Expert will support day-to -day Quality Assurance activities in accordance with approved SOPs / Policies for a multi-product, cGxP contract manufacturing facility in one of these areas: Quality Systems, QA Validation and Technical Compliance, Quality Compliance (Audit / External) or Quality Operations (LBT / LBSS).
What you'll do:
- Monitor day-to -day Quality Assurance activities in accordance with approvedSOPs / Policies for a multi-product, cGxP contract manufacturing facility
- Highly motivated individual and have superior skills in all areas relevant to the job
- A competent Reviewer and Approver of SOPs, protocols, reports or records
- Member of cross functional site team(s) on projects / issues
- Coordinate between departments for multiple parallel activities
- Superior ability to troubleshoot; able to identify process pathway and work to develop improvement in strategy site team(s) on projects/ issues
- Understanding of advanced topics pertaining to cGMP
- Participate in Regulatory Inspections or Customer Audits as required.
- Identify process pathway and work to develop improvement in strategy
- Help/Transfer and quickly assimilate to leadership role in other process areas
- Assume Supervisory responsibility in absence of supervisor
- Understand and articulate company business strategy. Maintain a broad view of the business, recognize changes and trend in the appropriate area in which the individual operates
- Any other tasks as and when assigned by supervisor
What we're looking for:
- Degree in science or related field
- Relevant work experience in Pharmaceutical Manufacturing industry or Validation / Quality unit in the Biopharmaceutical industry
- Familiar with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA, and ICHQ7)
- Knowledge and experience of the practical and theoretical requirement of quality management system in GMP facility
- 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.
R64909
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What We Do
At Lonza, we enable A Healthier World by supporting our healthcare customers on the path to commercialization. Our community of 16,000 talented employees work across a global network of more than 30 sites to deliver for our customers across the pharma, biotech and nutrition markets.
