Senior Specialist 2, Operations (Customer Project), QA

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 Senior Specialist QA, you will be handling customers and site projects within Quality Operations.

Key Responsibilities:

  • In depth awareness of entire process, identifying operational factors which influence the process. And provide QA assessment / input as required.

  • Develops good working relationships with internal & external customers.

  • Generally, provide compliance support to staff in all departments and as part of a project team.

  • Display a good level of problem-solving ability by analyzing and interpreting data and puts forward new ideas based on scientific knowledge or field experience.

  • Detect non-compliance with cGMP and GDP requirements and provide guidance on GDP corrections.

  • Support day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for a large scale, multi-product, GMP biotech manufacturing facility.

  • Participate in walk down and begin to provide usable feedback.

  • Participates in Regulatory and Customer Audits.

  • A competent Reviewer and Approver of documents (e.g. 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.

  • Able to participate actively or lead in investigations (e.g. deviations), change controls, CAPA plans and closure of discrepancy reports.

  • 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.

  • Ability to communicate effectively to internal and external stakeholders.

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

Reference: R56977