Senior Manager/ AGM- Quality Assurance

Oversight and Management

a. Manage and oversee all functions of the Quality Department.

b. Authorize quality-related documents.

c. Ensure overall compliance with GMP (Good Manufacturing Practices) requirements.

d. Implement and monitor Quality Systems at the site.

Management Representative (MR)

Batch Review and Approval

a. Review and approve Batch Manufacturing Records (BMR) for batch release.

b. Approve or reject each batch of the final materials.

c. Evaluate the quality and stability the final materials.

d. Establish shelf life and storage requirements based on stability testing.

Market Complaints and Recalls

a. Investigate market complaints and product failures.

b. Handle product recalls efficiently and effectively.

Audits and Training

a. Conduct GMP audits and training programs to ensure adherence to quality standards.

b. Perform periodic quality reviews and implement corrective measures as needed.

Documentation and SOP Management

a. Maintain and approve Standard Operating Procedures (SOPs) across the plant.

b. Ensure the completion and endorsement of all master production and control documents.

Quality Assessments and Investigations

a. Review and investigate Out-of-Specification (OOS) results and product failures.

b. Recommend appropriate corrective actions based on OOS findings.

c. Conduct additional sampling, inspections, and testing as required.

Vendor Management

a. Evaluate existing suppliers and qualify new vendors.

b. Conduct vendor audits for key raw materials based on requirements to ensure quality compliance.

Cross-Functional Coordination

a. Collaborate with other department heads to ensure seamless operations and adherence to quality standards.

Batch Release and Certification

a. Release batches for packing or sales after reviewing batch dockets and test reports.

b. Review and approve the Certificate of Analysis (COA) for the final materials.

Customer Commitments

a. Ensure adherence to customer commitments & regulatory compliances and address product complaints promptly.