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Quality Assurance Specialist
2 months ago
Job Summary:
This is a challenging role that requires a high level of expertise in regulatory affairs and quality assurance. As a Qualified Person, you will be responsible for ensuring compliance with cGxPs, SOPs, and regulatory requirements.
Key Responsibilities:
- Review and approve batch documentation and GMP requirements
- Ensure compliance with EU and US GMP regulations
- Identify and recommend process improvements to enhance quality and efficiency
- Manage outcomes and deviations, and ensure responses comply with regulations
- Support customers' needs and regulatory inspections
Requirements:
- Bachelor's degree in Science or a related field
- Excellent decision-making and problem-solving skills
- Ability to meet deadlines and streamline processes
- Knowledge of EU and US GMP regulations
- Excellent communication and interpersonal skills
About Lonza:
Lonza is a global leader in the life sciences industry, committed to delivering innovative solutions that improve human health and well-being. We value ethical achievement and environmental responsibility, and are dedicated to making a positive impact on the world.
