Technical/Functional
Skills

• Knowledgeable in 21 CFR Part
  11, Annex 11, and GAMP 5


• Updates validation
  procedures, including change control, training, and audits, to ensure the
  maintenance of system validation.


• Writes and reviews technical
  validation documents (e.g., validation plan, URS, FRS, Risk Assessment,
  Traceability Matrix, IQ/OQ/PQ/OPQ protocol, report, etc.)


• Assists in system validation
  project activities (e.g., writing protocols, reviewing/approving test
  scripts, drafting validation reports, etc.

Roles
&
Responsibilities

• 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.