Computer System validation Lead Job at Katalyst Healthcares & Life Sciences, South Plainfield, NJ

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  • Katalyst Healthcares & Life Sciences
  • South Plainfield, NJ

Job Description

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.

Job Tags

Permanent employment,

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