QA Specialist 2/3
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 Senior QA Specialist will lead and support day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for multi-product s and also provides QA support for Audit Management.
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.
A good understanding of cGxPs and compliance in a GxP manufacturing setting performing both supervised and unsupervised tasks
Receive minimal supervision and able to perform independently on routine assignments
Provide support in regulatory inspections and customer audits as required.
Revise, review and approve SOPs, protocols, reports or records.
Make real-time decisions on process events on the floor based on knowledge of defined SOPs & policies
Demonstrate appropriate interpersonal skills which encourage collaboration of individuals or teams to meet objectives.
Assist in deviation investigations, change controls and discrepancy reports.
Develop skills as an internal GxP auditor, as required• Any other tasks as and when assigned by supervisor.
Requirements:
Engineering/Science Degree or higher from recognized institution with 2-5 years’ experience in Validation / Quality unit in the Biopharmaceutical industry
Familiar with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA, and ICHQ7).
Good knowledge and experience of the practical and theoretical requirement of quality management system in GMP facility
Good interpersonal skills
Effective Communicator (oral and written)
Exhibit good quality decision making traits
Meticulous and Systematic
Analytical Mind
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.