Computer Systems Validation

  • Anywhere

Website Lachman Consultants

Lachman Consultants, the leader in providing cost-effective consultation and remediation services to the worldwide pharmaceutical, biotechnology, biologic, medical device, diagnostic and dietary supplement industries, is seeking Computer Systems Validation (CSV) experts:

  • Computer System Validation (CSV)
  • 21 CFR Part 11 compliance, assessment, and remediation
  • System Development Life Cycle Methodologies
  • Network infrastructure qualification / validation
  • Data Integrity audits for computerized systems
  • Risk Assessment
  • Standard Operating Procedures
  • Qualification and validation requirements; IQ / OQ / PQ protocols
  • LIMS validation
  • ERP validation
  • Trackwise
  • Documentum
  • Electronic signatures
  • Remediation of projects

Qualifications:

  • S. / M.S. / Ph.D. in Computer Science, Computer Engineering, or related area
  • Minimum of 10 years’ experience in pharmaceutical manufacturing or related environment
  • Detailed knowledge of current FDA, ICH, and USP regulations / guidances and expectations
  • Strong communication / presentation skills, verbal and written, are required for interaction with clients and coworkers
  • Ability to recognize and differentiate importance of issues and prioritize accordingly
  • Verifiable and recent “hands on” experience, including demonstrated remediation skills in the pharmaceutical industry
  • Domestic and international travel required

Send resume to: recruitment@lachmanconsultants.com or apply on line at: www.lachmanconsultants.com

For four decades, Lachman Consultants has been the leader in providing cost-effective consultation and remediation services to the worldwide pharmaceutical, biotechnology, biologic, medical device, diagnostic and dietary supplement industries. With its strong and extensive cadre of consultant specialists and an unparalleled management team, its Compliance, Science & Technology, and Regulatory Practices provide the most expert counsel and array of services available. Lachman Consultants is proud of its tradition of supporting industry efforts to develop and ensure safe, effective and high-quality medical products. It remains committed to helping the industry anticipate and address its challenges through the development and implementation of practical, sustainable and cost-effective solutions based on the integration of scientific principles, evolving regulatory expectations, and technology.

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