Head - Quality Assurance - Pharma

1. Overall responsible for Quality Assurance of Formulation at Baddi location.

2. Working out the human and materials resources required for Quality team.

3. Supervising, motivating the team and monitoring disciplinary matters.

4. Should serve as a Site Lead for facing various regulatory inspections like USFDA, MHRA, TGA and many more for Quality Assurance Activities.

5. Review Quality Overall Summary reports to be submitted to USFDA

6. Authorization of written procedures and other documents including amendments.

7. Involved in decision making process in all matters that affect the quality of products, including development, production, laboratory, storage, distribution and vendors.

8. Ensuring that teams adhere to robust quality standards & procedures through precision and monitoring sessions.

9. Monitoring, trending of non-conformances and ensuring effective corrective and preventive actions are implemented across the unit.

10. To ensure compliance with cGMP, statutory requirements. Liaison work with Government Departments and other statutory bodies. Keep track of national and international standards and legislation.

11. Notify concerned Qualified Person/Quality Assurance of the party in case of any changes made/proposed in the product.

12. To coordinate with concerned department heads for compliance of all audit points

13. Responsible to monitor, upgrade and maintain cGMP compliances at site.

14. To develop and establish robust quality systems at various applicable stages at plant operations and onwards.

15. Exposure to overall Quality system and compliance, including auditing, validations, documentation, Plant Operation compliance.

16. To lead the development and continuous improvement projects at site. Monitor quality improvement programs to assure timely correction and future problem prevention.

17. Review and approval of Quality Management System like Change Control, Deviation, Incident, product complaint and Out of Specifications/Trend.

18. To co-ordinate during quality audits by various Customer & Regulatory Agencies and ensure compliance to audit observations.