Manufacturing Quality Assurance Executive

JOB DESCRIPTION – QUALITY TEAM

Qualification: Bsc, Msc, D.Pharm, B.Pharm

Key Responsibilities

1. Regulatory Compliance and Licensing

   1. Coordinate the application, renewal, and modification of AYUSH, ISO, Organic, Halal, FDA, and other applicable certifications and licenses.

   2. Continuously monitor the FSSAI portal for license renewal, modification, annual returns, test report uploads, and other regulatory requirements.

2. Quality Documentation and SOP Management

2. Create, maintain, review, and update master quality documents.

3. Ensure that Standard Operating Procedures (SOPs) related to the storage, handling, inspection, and quality control of materials are established, maintained, and followed.

4. Ensure proper maintenance and traceability of quality records and documents.

3. Packaging Artwork Management

3. Maintain approved artwork files for all packaging materials.

4. Review new and revised packaging materials and verify artwork compliance with approved specifications and regulatory requirements.

4. Raw and Packaging Material Quality Management

4. Maintain specifications for raw materials and packaging materials.

5. Maintain and review Certificates of Analysis (COAs) to ensure compliance with defined safety and quality standards.

5. Project and Product Development

5. Participate in new product and project development activities.

6. Coordinate with relevant departments for quality and regulatory requirements associated with product development.

6. Stability Studies

6. Coordinate stability studies and ensure timely collection, review, and maintenance of stability study reports and related records.

7. Production and Batch Documentation

7. Maintain production batch details and assist the production team with batch coding requirements.

8. Review executed batch manufacturing/production records for completeness and compliance.

9. Maintain appropriate batch-related quality records and documentation.

8. Sampling and Laboratory Analysis

8. Arrange raw material and finished product samples for laboratory analysis.

9. Maintain the analysis sample register and ensure proper sample identification and traceability.

10. Coordinate the collection and review of laboratory test reports.

9. Employee Training and Medical Records

9. Maintain records of employee training and ensure that personnel are adequately trained in food safety, quality, hygiene, and other relevant areas.

10. Ensure that employee medical records are maintained, including routine health checks and vaccinations as required by applicable health and safety standards.

10. Pest Control Management

10. Oversee the pest control program and ensure that preventive and corrective measures are implemented effectively.

11. Monitor pest control activities and maintain relevant records to ensure continued compliance.

11. Patient and Laboratory Data Management

11. Review patient-related data as required for quality and clinical activities.

12. Catalogue and maintain laboratory reports in an organized and traceable manner.

12. Clinical Study Coordination

12. Coordinate with internal and external stakeholders for clinical studies.

13. Support the collection, documentation, review, and maintenance of clinical study-related records and reports.

13. Cross-Functional Coordination

13. Coordinate with Production, R&D, Laboratory, Clinical, and other relevant departments to ensure compliance with quality, safety, and regulatory requirements.

14. Support continuous improvement initiatives related to the Quality Management System.

Location : Bangalore RT Nagar,

Salary : 20000/-

Working days : Monday to Saturday

• It is a Full Time Manufacturing job for candidates with 1 - 2 years of experience.