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- To carry out the process validation: prepare protocol, follow-up the execution and report.
- To participate in cleaning validation:
- To follow-up and update the product list and equipment database
- To participate in development and validation of the related analytical method, if needed
- To follow-up cleaning validation runs and take sample
- To support to carry out the analytical method validation: prepare protocol and utility.
- To support to carry out the qualification of production equipment and utilities.
- To participate in investigation and handling of deviations during process validation and cleaning validation, to follow-up the execution of corrective actions and report the results.
- To participate in preparation of SOPs related to validation/ qualification.
- Any other duties related to validation/ qualification as assigned by Team leader.