Qualified Person

4 weeks ago


Slough, Slough, United Kingdom Lonza Full time

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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