Senior Specialist 1, QA
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 partners with the local supply chain team and global supplier quality to delivery quality across all the dimensions of supply chain. The role contributes directly to site business needs by delivering quality raw materials to to meet manufacturing production timelines and requirement while ensuring compliance to regulatory requirements. Through utilization of supplier qualification, supplier performance review and supplier complaints, the role also contributes directly to the strategic management of suppliers.
- Participate in supply chain oversight activities (eg approval of material packages, supplier management, supplier complaints, warehouse oversight)
- Liaise with global for supplier audit management
- Lead in deviation investigations, change controls, CAPA
- Review more complex decisions with supervisor and other departments
- Superior ability to troubleshoot, communicate and interact with cross functions and sites
- Identify process pathway and work to develop improvement in strategy
- Lead operational improvements
- Participate in customer / agency audits and inspections as required.
- Help/Transfer and quickly assimilate to leadership role in other process areas
- Assume supervisory responsibility in absence of supervisor
- Any other tasks as and when assigned by supervisor.
- Diploma with Significant years of experience in Quality Unit in the pharmaceutical / biotech industry
- Engineering / Science Degree from recognized institution
- Good understanding of GMP and close interaction with warehouses, Supply Chain.
- Experience in SAP, change management, deviation investigation, etc.
- Candidate should ideally come with supplier QA experience (material qualification, change management, vendor management ).
- Familiarity with Regulatory requirements and local Codes & Standards (e. g. , FDA, EMEA, andlCHQ7)
- Good interpersonal skills
- Effective Communicator (oral and written) to interact with diverse stakeholders (internal, global, customer, supplier)
- Exhibit good quality decision making traits
- Meticulous and Systematic
- Analytical Mind
- Team player, with strong focus on safety, quality and timeline.
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.