Pupose Of The Role :

- To lead Quality Operation team of sites to assure Quality of products, audit readiness at all times by ensuring implementation of training, right policies, procedures and adequate controls

- Responsible to lead Corporate Quality team for GMP remediation, develop system to ensure data integrity, Corporate Procedures harmonization, Vendor Management, Third Part Audits and Quality Improvement initiatives

- To host, lead and coordinate visits to the Sites by regulatory authorities

Key Accountabilities :

- Directly Responsible for overall Quality management for four sites and corporate Quality

- Formulate quality policies, system and procedures to meet regulatory and cGMP requirements

- To ensure that Standard operating procedures are followed to meet compliance requirements of the Site

- To ensure that the sites are ever ready for inspection

- To host and lead during audits of regulatory bodies such as USFDA/ MHRA - UK, Indian FDA and WHO

- To set an appropriate financial budget and ensure that the department operates within it

- To develop cost-effective ways of working to ensure compliance, service and safety

- To promote high standards of service for internal and external customers

- To optimize resources, utilize and develop skills across the Quality team to increase flexibility and to meet specific site business requirements

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