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Lead Auditor Crs

3 weeks ago

Việt Nam, Vietnam UL Solutions Full time

Conduct audits independently and collaboratively, ensuring compliance with cGMP and quality management standards (FDA CFR 820, CFR 210/211, ISO 22716).
- Manage and execute assigned audit programs without direct supervision.
- Work with Field Manager to expand technical expertise and audit scope over time.
- Meet process KPIs and monthly productivity targets.
- Represent ULS professionally, upholding impartiality and ethical standards.
- Prepare and distribute audit agendas to clients 14 days in advance (excluding unannounced audits).
- Submit audit results within four calendar days and review CAPA responses for acceptance or rejection.
- Lead and represent the audit team in management discussions, making final decisions on audit conduct and observations.
- Serves as a Competent Evaluator for field evaluations, supervising and assessing auditors during audits.
- Conduct field observations, witness audits, and issue competency reports on auditors' technical performance.
- Maintain specialized qualifications for advanced auditing skills and methodologies.
- Adhere to company policies on administration, confidentiality, business ethics, conflict of interest, and safety.
- Perform additional duties as assigned.
- Bachelor's degree in Electrical & Electronic Engineering with 4+ years of experience in manufacturing or quality assurance within the Medical Devices, Cosmetics or Pharmaceutical industries.
- 2 - 3 years’ GMP audit experience in the same industries.
- **Strong knowledge of FDA CFR 820, CFR 210/211, ISO22716 regulations is a must.**:

- Willing to travel across Southeast Asia regions (up to 80% annually).
- Fluent in English (proficiency in a second language is a plus).
- Excellent written and verbal communication skills; able to engage high-level executives and lead opening/closing conferences.
- Strong problem-solving skills with a creative and innovative approach to process improvements.
- Ability to lead audits teams for specialized projects.

A global leader in applied safety science, UL Solutions (NYSE: ULS) transforms safety, security and sustainability challenges into opportunities for customers in more than 110 countries. UL Solutions delivers testing, inspection and certification services, together with software products and advisory offerings, that support our customers’ product innovation and business growth. The UL Mark serves as a recognized symbol of trust in our customers’ products and reflects an unwavering commitment to advancing our safety mission. We help our customers innovate, launch new products and services, navigate global markets and complex supply chains, and grow sustainably and responsibly into the future. Our science is your advantage.