Qualified Person

1 day ago

Slough, Slough, United Kingdom Lonza Full time

At Lonza, we're a global leader in life sciences, operating across three continents. Our success is built on talented people working together to devise ideas that help businesses improve lives. In exchange, we empower our people to own their careers, driving genuine impact worldwide.

Key Responsibilities:

  • To ensure all processes, stages, and actions in manufacture, testing, and shipping adhere to cGxPs, SOPs, and regulatory requirements.
  • To review batch documentation, environmental monitoring data, investigation reports, change requests, SOPs, qualification reports, and GMP requirements.
  • To review and confirm batches according to manufacture and shipment schedules, ensuring all batches comply with regulatory requirements.
  • To assess quality-related issues and provide directions to relevant departments for efficient issue resolution.
  • To identify and recommend process improvements within the company's continuous improvement process.
  • Maintain eligibility to be named as a QP on required MIA and MIA (IMP).
  • Remove barriers and support continuous quality system improvement in line with current GMP expectations.
  • Manage outcomes and deviations, ensuring appropriate responses in compliance with regulations.
  • Work with QA and other departments to ensure CAPAs are SMART and closed by due dates.
  • Represent the QP Disposition process at tier level and general meetings.
  • Support customers' needs and provide timely responses to queries and communications.
  • Support regulatory inspections and customer audits of Operations areas and processes.

Requirements:

  • At least BSc in Science or QA discipline.
  • Excellent decision-making and problem-solving skills.
  • Ability to meet strict deadlines.
  • Ability to streamline processes.
  • Excellent organisational and planning skills.
  • Excellent knowledge and ability to interpret and translate EU and US GMP regulations and guidelines.
  • Excellent communication skills (verbal and written).

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