Sr Mgr, Quality Assurance

Job Description Summary

This position is responsible for ensuring that the final product observes the company’s quality standards and for the development and implementation of inspection activities, the detection and resolution of problems, and the delivery of quality product.

Job Description

• Review & approval of Process, Packaging validation, Submission and Engineering batch protocol/ report
• Master Batch record review (Validation, scale up, Exhibit, Engineering, Commercial)
• Executed Batch records review (Validation, scale up, Exhibit, Engineering, Commercial)
• Handling of New Product introduction activity
• Review & approval of protocols & reports as a part of Investigation
• Hold time study protocol/ report review & approval
• Review & approval of cleaning validation protocols, verification protocols and reports.
• SOP preparation and review
• Performing & Handling of self-inspection activity.
• Review & approval of risk assessments & impact assessment
• Root cause identification and Incident investigation activities
• Commercial dispatch activity as per site monthly schedule