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Senior Specialist 1, QA

2 weeks 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.

The QA Specialist will be responsible for performing day-to-day tasks of the QA Department in a GMP facility manufacturing clinical and commercial pharmaceutical products.

**Key responsibilities**:

- Monitor day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for a multi-product, cGxP contract manufacturing facility
- Highly motivated individual and have superior skills in all areas relevant to the job
- Review executed batch records and logbooks efficiently to ensure compliance with cGMP per written procedures
- Compile lot genealogy
- Participate actively and approve deviation investigations, utilizing Root Cause tools to enable effective and timely closure of deviation investigations
- Provide oversight to ensure correct implementation of CAPA based on deviation raised and ensure timely closure of CAPA
- Timely escalation of quality events on the floor based on knowledge of defined SOPs and policies
- Support changeover activities and QA on Call
- Provide training to new members and Participate in walkdown/ QA on Shopfloor and provide feedback to member of cross functional site team(s) on projects / issues
- 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
- Any other tasks as and when assigned by supervisor

**Key requirements**:

- Bachelor Degree with relevant work experience in Quality Assurance in the Biopharmaceutical industry.
- Relevant QA Operations background from the Biopharma environment.
- Hands-on experience coordinating & interacting with internal departments on manufacturing activities.
- Fair knowledge and experience of the practical and theoretical requirement of quality management system in a GMP facility.
- Familiarity with Regulatory requirements and local Codes & Standards (e. g., FDA, EMEA, andlCHQ7).
- Meticulous and Systematic.
- Team player, 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.