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This position is assigned for handling of change control system within the proposed timely and meet the GMP requirement.

Responsibility:

Provide data base of change control in the computerized system in order to track the change requested, follow up action plan as the timely manner, provide change control list for routine audit and client monthly report.
Primary review change control of each request in order to ensure that the change requested and reason for change is properly identified, action plans are sufficient to assess for each change.
Prepare and revise SOP related to change control in order to update the document complying with the current operating procedure and also follow GMP standard.