As a Senior Specialist you will support GMP operations in a dynamic biotech manufacturing environment. You will play a key role in maintaining quality standards while driving collaboration and continuous improvement.
What you’ll get
An agile career and dynamic working culture in a global life sciences leader.
An inclusive and ethical workplace that values diversity and integrity.
Competitive compensation programs that recognize high performance.
Professional growth opportunities through cross-functional projects and global exposure.
Comprehensive medical insurance, with the option to enroll family members at partially subsidized premiums.
Company transport provided from designated MRT locations to and from the Tuas site.
Access to Lonza’s full suite of employee benefits: www.lonza.com/careers/benefits
What you’ll do:
Support daily Quality Assurance activities in accordance with approved SOPs / Policies for a large scale, multi-product, GMP biotech manufacturing facility.
Planning for future activities and coordinate with other departments to complete the workflow.
Develop skills to be Qualified Trainer in area of expertise.
Develop in depth awareness of entire process; identifying operational factors which influence the process.
Participates in Regulatory and Customer Audits.
Support in performing gap assessments between group documents and or regulatory guidelines
Participate actively or lead in deviation investigations, change controls, CAPA plans and closure of discrepancy reports.
Ensure real-time decisions on process events on the floor based on knowledge of defined SOPs & policies.
Develops good working relationships with internal & external customers.
A competent Reviewer and Approver of SOPs, protocols, reports or records.
Lead a small team and provides supervision to QA Coordinators, interns or Specialists.
Any other tasks as and when assigned by supervisor.
What we’re looking for:
Bachelor's degree with 5-7 years’ experience in Quality Assurance in the Biopharmaceutical industry.
Relevant QA Operations background with experience in leading small team for projects.
Experience in deviation investigation, change control and CAPA activities.
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.
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.