QA Executive

Summary of Job Scope

• Responsible for process validation, cleaning validation, equipment hold time (clean & dirty), and hold time studies.
• Responsible for qualification of production equipment, premises, and critical utilities, including preparation, execution, and review of qualification activities.
• Coordinate and oversee temperature mapping studies for storage areas.
• Prepare, execute, review, and approve pre- and post-execution qualification and validation protocols and reports.
• Review and monitor the qualification and validation status of equipment, facilities, and critical utilities.
• Responsible for the Validation Master Plan (VMP) of the facility and oversee all Qualification & Validation activities.
• File incident reports/deviations, conduct investigations for validation-related issues, and propose, implement, and follow up on CAPA actions.
• Review and check Batch Manufacturing Records (BMR).
• Perf...