As a Specialist, QA (Quality External) at Lonza, you will monitor and support day-to-day Quality Assurance activities in accordance with approved SOPs and policies for a multi-product, cGxP contract manufacturing facility.
In this fixed term contract role, you will provide QA oversight in quality compliance and audits, support regulatory inspections, and collaborate cross-functionally to ensure the highest level of quality and compliance with cGMP standards.
What you'll get
- An agile career and dynamic working culture.
- An inclusive and ethical workplace.
- Compensation programs that recognize high performance.
- Daily company bus from the MRT location near your home to and from the Tuas site.
- Fully paid medical insurance, with the option to enroll family members at partially subsidized premiums.
- Access to Lonza's full global benefits portfolio:
What you'll do
- Support and participate in Regulatory Inspections and Customer Audits, including front room/backroom roles.
- Lead complex deviation investigations and review/approve deviations, change controls, trend investigations, supplier notifications, and CAPA plans.
- Perform material release and qualification, joint inspections, and vendor investigation reviews.
- Coordinate and deliver Supplier Quality Agreements in a timely manner.
- Own documents for assigned Quality Processes and support document management activities.
- Support continuous improvement, troubleshooting, and process pathway development for strategy improvements.
- Ensure adherence to data integrity principles in line with Lonza policies, proactively identifying and improving data integrity processes.
- Perform other duties as assigned by supervisor.
What we're looking for
- Degree or Diploma in Science, Science-related, or Engineering discipline.
- Experience in Quality Assurance within a cGMP manufacturing environment preferred.
- Knowledge of Quality Compliance, audits, and regulatory inspections.
- Strong problem-solving and troubleshooting abilities.
- Excellent communication, coordination, and stakeholder management skills.
- Ability to work independently while collaborating across functions.
- Motivated and proactive with the capability to assume leadership when required