Quality Assurance Expert Analytics, Drug Product Services
Randstad Inhouse Services is looking for a Quality Assurance Expert Analytics, Drug Product Services (m/f/d) for Lonza AG (100%). This is a temporary position from August 2022 until February 2023 with the option for extension or permanent hire.
Today, Lonza is a global leader in life sciences operating across three continents. While Lonza works in science, there’s no magic formula to how they do it. Their greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, they let their people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work Lonza wants to be part of.
- Establish and maintain Quality Management System for Drug Product Services
- Ensure proper qualification of DPS staff and adherence to GMP for stability studies and reference standards
- Review and approve methods, qualification/validation/transfer protocols and reports as well as analytic related SOPs
- Act as fist contact concerning compliance issues for local and shared systems (e.g. LIMS) including approval of specifications in LIMS
- Make sure all relevant parties adhere to GMP regulations and quality agreements
- Verify compliant qualification of suppliers, material, equipment, instruments (incl. CSV) and validation of methods and processes
- Supervise and execute GMP compliance activities and act as last approver of major deviations for Analytics/Quality Control and OOS investigations
- Counsel different groups on projects and GMP aspects
- Academic degree (Master or higher) in Chemistry, Biochemistry, Pharmaceutical Sciences or related field
- Significant working experience in Quality Assurance in pharmaceutical industries and cGMP controlled environment
- Good working knowledge in EU and US GMP regulations relevant for audit/inspections, qualification/validation, compliance systems
- Sound knowledge in testing of biological drug products
- Excellent communication and decision making skills
- Ability to work independently in a team environment
- Excellent knowledge of written and spoken English
Every day, Lonza’s products and services have a positive impact on millions of people. For Lonza, this is not only a great privilege, but also a great responsibility. How they achieve their business results is just as important as the achievements themselves. At Lonza, they respect and protect their people and their environment. Any success Lonza achieves 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, Lonza offers the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.