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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