Quality System and Validation Manager
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 Guangzhou Nansha Ltd was established in April 2003, expanding Lonza’s global presence for chemical manufacturing and life science ingredients.
Validation and qualification:
- Ensure transparent and effective communication with customer on validation/qualification topics and ensure alignment is made timely;
- Maintain the validation system to ensure the compliance with regulatory requirement;
- Review and approve qualification documents, including mechanical and I&E part;
- Organize process validation, review and approve all the protocols and reports, organize the continued process verification;
- Organize the cleaning validation, review and approve document related to the definition of cleaning strategy;
- Review and approve the annual review report for unitity systems, ensure all the reports can be finished on time;
- Review and approve the CRs and DRs related to equipment and facilities;
- Provide validation assessment for all CRs related to small molecule business unit;
- Organize the periodic review for all qualified equipment and facilities;
- Provide support to E&M department from QA perspective.
- Ensure internal audit, global QA audit, customer audit and health authority inspection is well organized, ensure enough support to the existing compliance team;
- Ensure well maintenance of quality culture and continuous improvement on quality culture;
- Ensure Data integrity policy is well maintained as expected, ensure all GMP computerized system is maintained according to procedures;
- Ensure supplier qualification system is well maintained, approve critical raw material suppliers.
- Ensure close communication with related brother sites and global QA, ensure no gaps for quality system and validation system;
- Deputy of Quality director for quality system and validation relevant activities;
- Coach and help the team member to solve the problems in routine work, manage and develop the team;
- Training and development of the team members;
- Perform other duties as assigned.
- Bachelor degree or above, major in Chemical or Pharmaceutical;
- Fluent in English;
- 10 + years sloid experience in validation and qualification in Chemical Drug product manufacturing industry;
- At least 5 + years in team management;
- Strong sense of responsibility.
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.