Match score not available

Computer System validation Lead

Remote:

Full Remote

Work from:

Connecticut (USA), Illinois (USA)

Offer summary

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 plans for healthcare computer systems.
Collaborate with cross-functional teams to ensure alignment with validation requirements.
Perform risk assessments and implement strategies for mitigation in computer systems.
Provide expertise on validation best practices and regulatory expectations.

Katalyst HealthCares & Life Sciences Pharmaceuticals SME https://www.katalysthls.com/

51 - 200 Employees

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.