Specialist 3 QA

Today, Lonza is a global leader in life sciences operating across five 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.

Responsibilities:

• 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
• Able to participate actively or lead in deviation investigations, change controls and CAPA plans
• Able to lead, review and approve deviation investigations, change controls and CAPA plan as required
• Perform material release and qualification, joint inspection to identify material defect and review vendor’s investigation report as required
• Review executed batch records and logbooks and ensure that deviations are raised
• Provides Quality oversight for Operations document changes (e.g. MBRs, SOPs, Forms, Logbook, etc.)
• Provides QA oversight in any customer project related activities

Requirements:

Bachelor's degree with 5-7 years’ experience in Quality Assurance 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

Good oral and written communication skills

Team player, with strong focus on safety, quality and timelines

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