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Computer System validation Lead

2 months ago


South Plainfield, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities and Requirements:
  • Conduct validation assessments for computer systems, software applications, and electronic records in compliance with healthcare regulatory requirements.
  • Develop and execute validation protocols, test scripts, and validation plans for computer systems used in the healthcare industry.
  • Collaborate with cross-functional teams, including IT, Quality Assurance, and Regulatory Affairs, to ensure alignment with validation requirements.
  • Perform risk assessments to identify potential vulnerabilities in computer systems and implement strategies for risk mitigation.
  • Provide expertise on validation best practices, industry standards, and regulatory expectations to internal teams.
  • Maintain accurate and up-to-date validation documentation, including validation reports, change control records, and standard operating procedures.
  • Participate in internal and external audits related to computer system validation and respond to audit findings as necessary.
  • Keep abreast of industry trends, regulatory updates, and technological advancements to enhance the validation process.