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Computer System validation Lead

Remote: 
Full Remote
Work from: 
Connecticut (USA), Illinois (USA)

Offer summary

Key responsabilities:

  • 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 logo
Katalyst HealthCares & Life Sciences Pharmaceuticals SME https://www.katalysthls.com/
51 - 200 Employees
See more Katalyst HealthCares & Life Sciences offers

Job description

Logo Jobgether

Your missions

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.

Required profile

Experience

Industry :
Pharmaceuticals
Spoken language(s):
Check out the description to know which languages are mandatory.

Soft Skills

  • Detail Oriented
  • Verbal Communication Skills

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