Specialist 3, QA
2 weeks ago
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 providing oversight into manufacturing in a large-scale, multi-product, GMP biotech contract manufacturing facility.
- Support day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for a multi-product, GxP contract manufacturing facility.
- In depth awareness of entire process, identifying operational factors which influence the process.
- 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.
- 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.
**Additional accountabilities of **Quality Operations**
- Review executed batch records and logbooks and ensure that deviations are raised.
- Compile lot genealogy.
- Escalate process events on the floor based on knowledge of defined SOPs & policies
- Support and coordinate changeover activities.
- Provides Quality oversight for Operations document changes (e.g. MBRs, SOPs, Forms, Logbook, etc.).
- Provides Quality Change Request oversight for process and Operation change.
- Detect non-compliance with cGMP and GDP requirements and provide guidance on GDP corrections.
- Participate in walk down/ QA On Shopfloor and provide feedback.
- Participates in Regulatory and Customer Audits.
- Leads and coordinate projects and manages the deliverables effectively.
- Develops good working relationships with internal & external customers.
- Able to troubleshoot. Able to weigh up all information and considerations in order to choose the optimum path to be taken.
- Able to be Change Agent, Reviewer or Approver of SOPs, protocols, reports or records.
- Able to participate actively or lead in deviation investigations, change controls and CAPA plans.
- Able to assist in deviation investigations and change controls.
- Provides guidance to QA Specialists 1 and 2 as required.
**Requirement**
- Degree from recognized institution with 3 to 5 years’ experience in a similar type of industry or a similar job role. (QA Specialist 3)
- Diploma with 5 - 7 years’ experience in a similar type of industry or a similar job role. (QA Specialist 3)
- 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.
- Meticulous and Systematic, team player, with strong focus on safety, quality and timelines.
- Able to operate independently with minimum supervision (QA Specialist 3).
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.
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