Senior Quality Assurance (QA) Validation Specialist

China, Nansha

Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

As Senior QA Validation Specialist, you will represent the QA Validation department and act as a liaison between QA Validation and its internal and external customers. You also need to utilize your knowledge and technical experience to complete a variety of tasks and to ensure all critical GMP equipment and systems are validated and maintained in compliance with user requirements, process parameters and global regulatory guidelines.

Key responsibilities:

  • Monitor day-to-day Qualification & Validation activities in accordance with approved Policies/SOPs / Plan for API manufacturing facilities and equipment.
  • Participate in review and approval of series of Qualification documents (URS/ QP/RA and DQ/IQ/OQ/PQ plans / Reports, including handling of any discrepancies, deviations and changes during qualification and validation.
  • Support / participate in Site Validation & Qualification Maintenance Program to ensure GMP facilities and equipment are continuously maintained in a validated state.
  • Actively co-ordinate with internal and external validation resources to achieve department / project goals
  • Perform change control assessments for GMP equipment and associated validation activities to ensure compliance with regulatory requirements.
  • Review and approve the CRs and DRs related to equipment and facilities.
  • Participate in Customer / Agency Audits and Inspections as required
  • Participate in on-job training program for staff
  • Any other tasks as and when assigned by supervisor

Key requirements:

  • Bachelor’s Degree with a field of chemical or pharmaceutical engineering discipline preferred.
  • Solid experience in Qualification and validation in API manufacturing environment with strong knowledge of FDA, EMA and Chinese GMP regulation requirements regarding qualification and validation.
  • Strong multi-task management & independency ability.
  • Good communication skills and self-motivated.
  • Business fluent at English preferred.

Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Reference: R27808