QA Customer Interface Manager
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.
Key responsibilities:
- Monitor, evaluate and manage the activities performance of compliance customer management function in order to ensure all customer & consumer issues/complaint being handled according to corporate standard quality and procedure.
- Control and ensure that complaint handling is properly investigate and response timely in coordination with Head of Quality. Checking and approve reply letter to the customer regarding the results of an investigation of customer complaints, ensuring that the analytical data is accurate and delivered on time, in order to achieve customer satisfaction in coordination with Head of Quality.
- Initiate CAPA related to complaint (for justified & for complaint which needed CAPA) & issued to QA Compliance CAPA Team.
- Handling customer audit and provide customers with statement letters.
- Proactively visit to customers both domestic and export in coordination with Technical Service Engineer/Territory Sales Manager/Sales Manager to handle customer focus on complaint investigation & resolve complaint purposes.
- Manage return product (capsule product return by customer).
- Manage mock recall & recall product (capsule product recall by regulatory).
- Manage Customer Quality Agreement aligned with Global procedure and per customer’s requirements.
- Coordinate implementation & approve special requirement system to ensure its build into products.
- Coordinate with operation team for complaint investigation and improvement plan of complaint.
- Provide prompt feedback to Sales Team & Technical Service, with related to quality capsule issue which not yet submit as complaint but may lead to complaint or feedback to clarify whether it is not appropriate to be complaint.
Key requirements:
- Bachelor’s Degree or higher in Chemistry, Microbiology, or Life Sciences, Pharmaceutical, or equivalent scientific discipline.
- Minimum 6 years of experience in quality or regulatory compliance within the pharmaceuticals, biologics, or other related industry.
- Proven track record in customer quality & engagement, complaint management and partnering with internal departments.
- Good Manufacturing Practice experience, or experience in a highly regulated industry.
- Experience with supporting product inspections from local Regulatory Authorities.
- Effectively represent Quality Assurance, both internally and externally.
- Good communication skills (Both English and Local Language).
- This role will be onsite at manufacturing unit of Lonza.
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 achieved 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.