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Validation Engineer
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☞ CÔNG TY TNHH THƯƠNG MẠI MEDLINE VIỆT NAM
Ver: 185
Día de actualización: 14-04-2024
Ubicación: Ha Noi Ho Chi Minh
Categoría: Seguro de Calidad / Control de Calidad Farmacéutica / Química / Biotecnología
Posición: Nhân viên
Salario: Cạnh tranh
Educación: Đại học
Experiencia: 1 - 2 Năm
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Descripción del trabajo
- Work as project manager and perform validations related to sterility assurance of sterile medical devices from vendors in Asia, including but not limited to
- ETO sterilization validation
- Steam sterilization validation
- Packaging validation
- Supervise and train vendors for ISO standards and Medline requirements
- Perform audits and vigilance audits for sterile products related quality system and process; follow up CAPA/ SCAR and ensure appropriate evidences in a timely manner
- Perform root cause investigation, troubleshooting and problems solving when non‐ expected situation happens.
- Perform new products adoption into validated sterilization cycle including but not limited to bioburden, residual evaluation, packaging evaluation, etc.
- Manage conflicts, interact with vendors and stakeholders, and communicate with internal team and cross‐functional teams.
- Intensive travels to vendors to ensure meeting quality requirements.
- Other work assigned by supervisor.
Requerimiento de trabajo
Education
- Bachelor’s degree or above with science or engineering background. Biological and chemical background is preferred.
Relevant Work Experience
- 1‐2 years’ work experience in manufacturing. Experience in medical device is an advantage.
- Fluent at both verbal and written English.
- Microsoft Word and Excel experience at an intermediate level
- Willing to travel with rate 50%
- Good teamwork spirit, Good problem solving skills
- Familiar with requirements and standards related to ISO11135, ISO11607 is preferred
- Project management skill is a plus
Beneficio laboral
- Chế độ bảo hiểm
- Du Lịch
- Chế độ thưởng
- Chăm sóc sức khỏe
- Đào tạo
- Tăng lương
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Plazo: 14-05-2024
Haga clic para postularse como candidato gratuito
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