Specialist 1, QA

Singapore, Tuas SingaporeToday, 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 to provide oversight to manufacturing in a large scale, multi-product, GMP biotech contract manufacturing facility.

**Key responsibilities**:

- Support day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for a multi-product, GxP contract manufacturing facility
- Take on role of QA Specialist in one of 6 areas: Quality Systems, QA Engineering, External QA, QA Excellence (Transformation and Technical Compliance), Quality Operations or Audit Management. - In depth awareness of entire process; identifying operational factors which influence the process
- Lead a small team and provides supervision to QA Coordinators, interns or QA Specialists 1 and 2
- A competent Reviewer and Approver of SOPs, protocols, reports or records
- Can trouble-shoot and able to weigh up all information and consideration in order to choose the optimum path to be taken.
- Demonstrate ability to lead a small project and manage the deliverables effectively.
- Develop good working relationships with internal & external customers.
- Able to participate actively or lead in deviation investigations, change controls, CAPA plans and closure of discrepancy reports.
- Develop skills as an internal GxP auditor, as required.
- Provide support in regulatory inspections and customer audits as required.
- Plan for future activities and coordinate with other departments to complete this - Develop skills to be Qualified Trainer in area of expertise.
- Any other tasks as and when assigned by supervisor.

**Key requirements**:

- Bachelor's 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.

We provide company transport, both ways, at multiple pick-up points.

**Reference: R54447**: