Senior Specialist 2, QA (Audit Management)
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.
The role will support Lonza Singapore Operations with the management and execution of the internal and external audit programs. The role will also assist with the management of quality risks associated with GMP compliance at site level.
- Monitor day-to-day Quality Assurance Audit Management Team activities in accordance with approved SOPs / Policies for a large scale, multi-product, and GMP biotech contract manufacturing facility
- Highly motivated individual and have superior skills in all areas relevant to the job
- Superior ability to troubleshoot
- Understanding of advanced topics pertaining to cGMP
- Oversight and maintain Internal Audit Program
- Perform internal audit as qualified lead auditor / co-auditor
- Coordinate between departments for responses for audit findings and gap analysis
- A competent Reviewer and Approver of SOPs, responses for audit findings and gap analysis
- Participate in Customer / Agency Audits and Inspections as required
- Plan and lead preparation effort for external regulatory inspections, customer audits and Lonza Corporate audits
- Identify process pathway and work to develop improvement in strategy
- Help/Transfer and quickly assimilate to leadership role in other process areas
- Assume Supervisory responsibility in absence of supervisor
- Understand and articulate company business strategy. Maintain a broad view of the business, recognize changes and trend in the appropriate area in which the individual operates
- Any other tasks as and when assigned by supervisor.
- Degree / Diploma from recognized institution with significant experience in a similar type of industry or a similar job role
- Experience in performing Quality internal audits or participating in regulatory inspections
- Hands-on experience coordinating & interacting with internal departments on manufacturing activities
- Familiar with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA, and ICHQ7)
- Good knowledge and experience of the practical and theoretical requirement of quality management system in GMP facility
- Good interpersonal skills
- Effective Communicator (oral and written)
- Exhibit good quality decision making traits
- Meticulous and Systematic
- Analytical Mind
- Team player who can operate independently, with strong focus on safety, quality and timelines.
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 achieve 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.