Quality Operation Specialist

China, Guangzhou

Today, Lonza is a global leader in life sciences operating across three continents. 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.

Lonza is establishing a strategic biomanufacturing base in China using GE Healthcare Solutions. With the new facility, Lonza is responding to growing demand for a high-quality CDMO in the Chinese market.

As QA Specialist, Engineering, you need to support day-to-day Validation and routine engineering activities in accordance with approved Standard Operation Procedure / Policies for a large scale, multi-product, and Good Manufacture Practices biotech contract manufacturing facility; Generally provide documentation and area monitoring & supervision; A good understanding of cGMP and technical knowledge should well support the tasks above.

Key responsibilities:

  • Monitor day-to-day Validation activities in accordance with approved SOPs / Plan / Policies for a small scale, multi-product, GMP biotech contract development/manufacturing facility through way of working below:
    • Support / participate in validation activities during facility startup /shutdown / changeover and routine GMP operations
    • Support / participate in Site Validation Maintenance Program and implementation of department training requirements
    • Participate in review and approval of Validation Protocols / Reports including site discrepancies and deviations investigation / closure
    • Issue and update SOP related to validation. Execute gap analysis of globe documents related to validation. Organize and provide the site level technical training related to validation to enhance the competence level at site level.
    • Active co-ordination with internal and external validation resources to achieve department / project goals. Liaise with system owners, and other relevant departments to ensure scope, execution and reporting of Site Validation Program meet expectations
    • Review & assess Site Change Controls, implementation of Validation CAPAs and subsequent closure.
  • Participate in Customer / Agency Audits and Inspections as required
  • For Routine Engineering activity:
  • Monitor day-to-day routine engineering activities through way of working below:
  • A competent Reviewer of SOP or records, protocols/reports belong to engineering area, which may including engineering utility system, maintenance activity or automation/ calibration management;
  • Handling deviation and Corrective and Preventive Actions in Trackwise System (TW); Able to assist in deviation investigations and discrepancy reports;
  • Able to develop skill as an internal cGMP auditor;
  • Provide training and technical advice to other staffs as required;
  • Identify situation which may require escalation to supervisor;
  • Any other tasks as and when assigned by manager

Key requirements:

  • Relevant experience and accomplishment to dictate final position for which the candidate may qualify
  • Good problem solving and analytical skills
  • Good communication skills
  • Decision Making
  • Planning/Organizing
  • Effective Communication
  • Personal Orientation
  • Teamwork

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: R38973