Job description for IT Quality & Data Integrity Officer at Kalbio Global Medika
Requirements :
Bachelor’s degree in computer related degree, pharmacy, or relevant major in life sciences or engineering.
Minimum 1 year experience in data integrity in a GxP environment.
Able to communicate in English and Bahasa.
Understand basic scripting of programming is a plus.
Job Descriptions :
Maintain, establish, and / or evaluate procedure(s) regarding computerized system validation and data integriy as per updated guideline and Quality Manual.
Establish Validation Plan and Schedule of Computerized System.
Generate or review any protocol and report related to computerized system validation and data integrity.
Implement qualifications and validations of computerized systems and equipment.
Investigate any technical deviations associated with related task.
Implement IT Quality aspects including but not limited to user access management, backup and restore management, time synchronization, audit trail review, and user access periodic review.
Implement GMP, GaMP, and data integrity principles.
