Specialist 2, Quality Assurance

Singapore, Tuas Singapore

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.

As a QA Specialist you will support day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for a multi-product, GxP contract manufacturing facility

Key Responsibilities

  • 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

  • Able to participate actively or lead in deviation investigations, change controls, CAPA plans and closure of discrepancy reports

  • Assist in deviation investigations, change controls and discrepancy reports

  • Develop skills as an internal GxP auditor, as required

  • Provide support in regulatory inspections and customer audits as require and plan for future activities and coordinate with other departments .

  • Any other tasks as and when assigned by supervisor

Key Requirements

  • Bachelor Degree in Engineering/Science Degree or higher from recognized institution with 3 to 5 years’ experience in Validation / Quality unit in the Biopharmaceutical industry

  • Familiarity with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA, and ICHQ7)

  • Fair knowledge and experience of the practical and theoretical requirement of quality management system in a GMP facility

  • Able to operate independently with minimum supervision for routine work within established policies and procedures, and receives detailed instructions on new projects and assignments.

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.

Vaccination status: As the above role requires you to work on-site*, only fully vaccinated** employees will be shortlisted for the role.  For fully vaccinated applicants, please indicate your vaccination status as “fully vaccinated” when applying for the role.

*In line with the latest advisory from the Ministry of Manpower, from 1 January 2022 only employees who are fully vaccinated or have recovered from COVID-19 within the past 180 days, can return to the workplace.

** Lonza adopts the definition of “fully vaccinated” by the Ministry of Health in Singapore which means that you:

(a) have received the full regimen of WHO EUL vaccines from a specific manufacturer; and

(b) have met the prescribed post-vaccination period for the respective vaccine to be fully effective.

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

Reference: R48401