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Global drug and device development services

Validation Analyst - Labs

Regulatory & Quality (Life Sciences)Posted on Nov 10
Full-timeBeijing, China

About the Job

Requirements

  • A bachelor's degree in Life Sciences, Engineering, Computer Science, or a related field is required.
  • At least 2 years of experience in laboratory validation, quality assurance, or a related role within the pharmaceutical, biotechnology, or clinical research industry is required.
  • A strong understanding of regulatory requirements, including FDA, EMA, and ICH requirements governing laboratory operations and validation activities, is required.
  • Proficiency in validation methodologies, documentation practices, and quality management systems is required.
  • The ability to work effectively in a cross-functional team environment is required.
  • Willingness to travel as required, approximately 5%, is required.
  • The employee must have the legal right to work in the country where the role is based.

Responsibilities

  • Collaborate with laboratory and quality assurance teams to develop and execute validation protocols and test plans for laboratory instruments, equipment, and software systems.
  • Conduct validation testing, data analysis, and documentation in accordance with regulatory requirements and industry standards.
  • Identify and troubleshoot validation issues, deviations, and non-conformances, and implement corrective and preventive actions as needed.
  • Provide technical expertise and guidance on validation strategies, best practices, and regulatory expectations to project teams and stakeholders.
  • Contribute to continuous improvement of laboratory processes, systems, and validation methodologies.

About the Company

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Global drug and device development services

This company provides consulting, development, and commercialization support for drugs and medical devices through a global network of offices. Its team across 53 countries offers end-to-end services, from strategy and regulatory work to manufacturing and market access, helping clients shorten development time, lower costs, and raise quality. It differentiates itself with wide geographic reach and a clear focus on reducing time to market and cost while leveraging deep experience across many therapeutic areas. Its goal is to help clients accelerate the development of life-saving products and improve quality of life by delivering reliable information, practical solutions, and solid performance.

Company size
10,001+
Company stage
IPO
Headquarters
Ireland
Founded
1990

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