QA Officer - BIO Section

• Perform and supervise daily Bio Lab activities and microbiological testing; Conduct bioburden, endotoxin, sterility testing and environment monitoring; Make record, review and report test results accurately and timely

• Perform/Support the preparation and revision of SOPs, test method and validation documents; Ensure testing activities comply with SOPs, ISO 13485 and applicable quality requirements;

• Perform/Support investigations of OOS/OOT, deviations and abnormal test results, including NCR, CAPA activities … Maintain laboratory equipment, materials, reagents and related records;

• Train and support Bio Lab members to ensure technical competency; Support Bio Lab activities and technical transfer at overseas facilities when required

Yêu cầu công việc

• Male/ Female, under 40 years old;

• Bachelor’s degree or higher in Microbiology, Biology, Biotechnology, Biochemistry or related fields;

• 5-7 years of relevant experience in microbiology/ Bio laboratory operations, preferably in the medical device or pharmaceutical industry;

• Strong practical experience in bioburden, endotoxin, inhibition, Gas Chromatography, sterility testing and environment monitoring …;

• Good knowledge of ISO 13485, 10993-7, 11737-1/2, 11135, 14644/14698, GMP/GLP, microbiological testing and laboratory quality systems;

• Experience in team leadership, laboratory management, equipment management and handling OOS/OOT, deviations, root cause analysis and CAPA;

• Strong analytical, problem-solving, communication and cross-functional collaboration skills;

• Good English communication skill; Japanese/ Chinese skills are an advantage;

• Willing and able to undertake long-term overseas business trips/ assignments as required;

Benefits:

- Attractive salary and annual salary increases and bonuses;

- 99 days off per year

- Company car provided for daily working;

- Allowances for lunch, transportation, housing, seniority, position, etc.;

- Health insurance for yourself and your family;

- Full benefits of social insurance, health insurance, and unemployment insurance as regulations;

- Working in a clean and professional environment

- Annual health check-ups and occupational disease screenings

- Participation in sports, cultural, and artistic activities organized by the company's labor union

Note:

- Please attach CV when applying job

- Only contact with qualified candidates

Quyền lợi

• Thưởng: Attractive salary and annual salary increases and bonuses
• Chăm sóc sức khoẻ: Health insurance for yourself and your family
• Nghỉ phép có lương: 99 days off per year
• Hoạt động nhóm: Participation in sports, cultural, and artistic activities organized by the company's labor union
• Xe đưa đón: Company car provided for daily working
• Khác: Allowances for lunch, transportation, housing, seniority, position, etc.
  Full benefits of social insurance, health insurance, and unemployment insurance as regulations
  Working in a clean and professional environment
  Annual health check-ups