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Regulatory Compliance Specialist

3 months ago

Slough, Slough, United Kingdom Lonza Full time

Role Overview:

  • Execute responsibilities as a Regulatory Compliance Specialist as stipulated in industry regulations.
  • Examine documentation pertinent to production and quality assessment.
  • Assist Quality Assurance leadership in overseeing the Pharmaceutical Quality Management System.
  • Offer expertise on Quality issues to foster ongoing enhancements.

Primary Responsibilities:

  • Guarantee adherence to current Good Practices (cGxPs), Standard Operating Procedures (SOPs), and regulatory mandates.
  • Scrutinize batch records and Good Manufacturing Practice (GMP) standards.
  • Validate batches for conformity with regulatory guidelines.
  • Detect and propose enhancements to processes.
  • Oversee outcomes and deviations, ensuring that responses align with regulatory standards.
  • Support client requirements and regulatory audits.

Required Qualifications and Skills:

  • Bachelor's degree in a scientific field or Quality Assurance discipline.
  • Strong decision-making and analytical skills.
  • Capability to adhere to deadlines and optimize workflows.
  • Familiarity with EU and US GMP regulations.
  • Exceptional communication abilities.

This position provides a chance to significantly impact the life sciences sector. Lonza is committed to ethical practices and environmental stewardship. Join us in addressing intricate challenges and enhancing lives globally.