Qualified Person
4 weeks 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/Regulatory requirements.
Key Responsibilities:
- Review and approve batch documentation and GMP requirements to ensure compliance with regulations.
- Conduct regular audits and inspections to identify areas for improvement and implement corrective actions.
- Develop and maintain procedures for quality control, quality assurance, and regulatory compliance.
- Collaborate with cross-functional teams to ensure that quality and regulatory requirements are met.
- Provide guidance and training to colleagues on regulatory affairs and quality assurance best practices.
- Stay up-to-date with changes in regulations and industry standards to ensure that the company remains compliant.
Requirements:
- Bachelor's degree in a scientific or quality assurance discipline.
- Minimum 5 years of experience in a quality assurance or regulatory affairs role in the pharmaceutical industry.
- Excellent communication and interpersonal skills.
- Ability to work in a fast-paced environment and prioritize multiple tasks.
- Strong analytical and problem-solving skills.
About Lonza:
Lonza is a global leader in the life sciences industry, with a commitment to innovation, quality, and customer satisfaction. We offer a dynamic and challenging work environment, with opportunities for professional growth and development.
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