Main Responsibility:
1. Conduct the routine monitoring for sterilization vendor, liaise with serialization vendor to carry out the product sterilization and sterilization process validation.
2. According to regulation requirements, perform sterilization process revalidation periodically.
3. Conduct the final product sterilization release and routine product quality sampling test (LAL test, ETO residual test, other necessary tests).
4. Establish quality specification, SOP, and working instruction, according to corporate and local quality requirement.
5. Conduct the related process quality NC handling, change controls and complaint investigation.

Required Skills/Knowledge:
1. 1 year working experience in sterilization area, above 1 year in EU/US company is preferred.
2. At least 2 years working experience in GMP environment of medical industry is preferred.
3. Familiar with ISO9001, GMP and validation.
4. Be familiar with sterilization process quality controls.
5. Be familiar with production process quality controls is preferred.
6. Good computer and software skills.
7. Bachelor’s degree, majored in science of Microbiology, Biochemistry, pharmaceutical, food etc.
8. ISO 11135 or ISO11137 certificate is preferable.
9. Good English communication both in oral and written.

Personal Quality:
1. Self-motivated and initiative, able to work under pressure.
2. Great Systematic& Logical thinking.
3. Excellent team-work spirit.
4. Great communication skills with cross-function.