Computer Systems Validation Specialist

2 days ago

Singapore beBeeCompliance Full time

Job Title: Computer Systems Validation Specialist

  • Develop and implement comprehensive validation strategies to ensure compliance with domestic and international regulations, including GxP, GAMP5, ERES, and Data Integrity.
  • Prepare and maintain all necessary validation documents, such as validation master plans, validation plans, and risk assessments, ensuring alignment with regulatory requirements.
  • Execute validation protocols and prepare detailed summary reports, highlighting key findings and recommendations for improvement.
  • Manage change control for validated systems, performing thorough impact assessments to mitigate risks associated with changes to validated systems.
  • Provide training on CSV principles and procedures, fostering a culture of quality and compliance within the organization.
  • Ensure seamless collaboration with cross-functional teams to execute validation activities efficiently and effectively.
  • Requirements:
  • Must have experience in a CSV role within the pharmaceutical industry.
  • Strong knowledge of GMP, GAMP5, ERES, and Data Integrity is essential.
  • Excellent communication and organizational skills are required to excel in this role.

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