The QA Specialist will be responsible to provide oversight to manufacturing in a large scale, multi-product, GMP biotech contract manufacturing facility.
What you will 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, and option to enroll family members at partially subsidized premiums.
Our full list of global benefits can be found here: https://www.lonza.com/careers/benefits.
What you will do
Support day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for a multi-product, GxP contract manufacturing facility
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.
Able to participate actively or lead in deviation investigations, change controls, CAPA plans and closure of discrepancy reports.
Develop skills as an internal GxP auditor, as required.
Provide support in regulatory inspections and customer audits as required.
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.
What we are looking for
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.
About Lonza
At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.
Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.
Ready to shape the future of life sciences? Apply now.
Lonza is a pioneer and world leader in the CDMO industry, setting the pace with cutting-edge science, smart technology, and lean manufacturing. United by a common purpose, we turn our customers’ breakthrough innovations into viable therapies and manufacture the medicines of tomorrow.
Founded in Switzerland in 1897, our company is the first and original CDMO, and today we are more dynamic, agile and forward-focused than ever before. As one of the largest Western CDMOs, we bring together a global team of around 18,500 colleagues across five continents to deliver comprehensive, integrated solutions for our customers' complex needs.
For our customers and their patients, we bring quality, safety and reliability to bring life-enhancing and life-saving treatments to market at speed and at scale. For our colleagues, we strive to create a sense of belonging and inclusion where every person can thrive and bring their best.
