Role & responsibilities

1.To ensure a robust system is developed and maintained to ensure Data Integrity is assured.

2. To ensure that the sites quality system is in compliance to applicable regulatory requirements where the products are being marketed.

3. To ensure that quality systems are developed, implemented and maintained.

4. To ensure that the raw material suppliers are qualified as per the applicable procedures.

5. Oversee investigations of all non-conformances (Incidents, deviations, OOS, market complaints, errors, etc.).

6. Ensure that cGMP requirements and quality standards are recognized, understood, and maintained across the Company.

7. To ensure qualification and validation are performed as per SOP and regulatory requirements for Process, cleaning, systems, equipment, and computerized system.

8. Work across all disciplines (e.g. manufacturing, warehouse & QC, etc.) to ensure that the Company maintains a state of readiness for inspection by regulatory agencies.

9. Keep abreast of changes to quality regulations and guidelines,



advising the management team of any business implications of these changes. Lead, manage, and ensure proper training to any relevant change management programs throughout the company.

10. Provide quality guidance to product development projects and programs.

11. Maintaining and improving departmental operational performance, to meet the requirements of regulatory authorities, company Standard Operating Procedures (SOPs), and external and internal customers, with respect to quality, service, lead time, and cost.

12. Ensuring the development of departmental SOPs (writing, revising, and approving), ensuring regulatory compliance in conjunction with being - fit for purpose- operationally and commercially.

13. Ensuring that all activities are performed in accordance with GMP, company SOPs and Health and Safety policies.

14. Ensuring that there is a self-inspection program in place that is communicated to Operations to meet

📌 Head Quality Assurance (Baddi)
🏢 Acme Formulation
📍 Baddi